Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00703118
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2008-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C486464', 'term': 'telaprevir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1 609 730-3174', 'title': 'Medical Leader', 'organization': 'Tibotec'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '72 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'T12/PR48 - TVR/PBO TREATMENT', 'description': '12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase', 'otherNumAtRisk': 266, 'otherNumAffected': 253, 'seriousNumAtRisk': 266, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'T12(DS)/PR48 - TVR/PBO TREATMENT', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase', 'otherNumAtRisk': 264, 'otherNumAffected': 255, 'seriousNumAtRisk': 264, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Pbo/PR48 - TVR/PBO TREATMENT', 'description': '48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the telaprevir/placebo treatment phase', 'otherNumAtRisk': 132, 'otherNumAffected': 126, 'seriousNumAtRisk': 132, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'T12/PR48 - OVERALL TREATMENT', 'description': '12 weeks of 750 mg telaprevir q8hr followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase', 'otherNumAtRisk': 266, 'otherNumAffected': 257, 'seriousNumAtRisk': 266, 'seriousNumAffected': 33}, {'id': 'EG004', 'title': 'T12(DS)/PR48 - OVERALL TREATMENT', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir q8hr in combination with 48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AES during the overall treatment phase', 'otherNumAtRisk': 264, 'otherNumAffected': 260, 'seriousNumAtRisk': 264, 'seriousNumAffected': 32}, {'id': 'EG005', 'title': 'Pbo/PR48 - OVERALL TREATMENT', 'description': '48 weeks of Peg-IFN-alfa-2a and RBV at standard doses - TE AEs during the overall treatment phase', 'otherNumAtRisk': 132, 'otherNumAffected': 126, 'seriousNumAtRisk': 132, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 78}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 93}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 38}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 35}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 43}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 36}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 66}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 69}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 40}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 32}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 94}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 87}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 31}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 51}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 60}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 31}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 124}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 145}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 131}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 85}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 94}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 38}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 59}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 71}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 36}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 31}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 42}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 23}, {'groupId': 'EG002', 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11.0'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 266, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 266, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T12/PR48', 'description': '12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG001', 'title': 'T12(DS)/PR48', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG002', 'title': 'Pbo/PR48', 'description': '48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage of response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.8', 'ciLowerLimit': '36.8', 'ciUpperLimit': '56.7', 'pValueComment': 'Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure', 'estimateComment': 'Difference in percentage of response was estimated through the logistic regression model.', 'groupDescription': 'Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage of response', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '49.8', 'ciLowerLimit': '39.9', 'ciUpperLimit': '59.7', 'pValueComment': 'Overall significance level was set at 5% (two-sided). Adjustment of significance level for multiple comparisons was carried out using the Hochberg procedure', 'estimateComment': 'Difference in percentage of response was estimated through the logistic regression model.', 'groupDescription': 'Null hypothesis: Assuming a 55% response rate in the groups receiving Treatment T12/PR48 or T12(DS)/PR48, a 29% response rate in the group receiving Treatment Pbo/PR48, a 2-sided continuity corrected Chi-squared test, with an overall significance level of 5% and a 2:2:1 randomization, a sample size of 140 patients receiving Treatment T12(DS)/PR48 and 70 patients in receiving Treatment Pbo/PR48 provided a power of approximately 90% to demonstrate a statistically significant difference.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Included: treatment, type of prior response (relapser, partial responder, null-responder) and their interaction, and baseline HCV RNA as a covariate', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 72', 'description': 'SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T12/PR48', 'description': '12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG001', 'title': 'T12(DS)/PR48', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG002', 'title': 'Pbo/PR48', 'description': '48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}], 'classes': [{'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T12/PR48', 'description': '12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG001', 'title': 'T12(DS)/PR48', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG002', 'title': 'Pbo/PR48', 'description': '48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}], 'classes': [{'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T12/PR48', 'description': '12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG001', 'title': 'T12(DS)/PR48', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG002', 'title': 'Pbo/PR48', 'description': '48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}], 'classes': [{'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 60', 'description': 'SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T12/PR48', 'description': '12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG001', 'title': 'T12(DS)/PR48', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, Week 6, or Week 8', 'description': 'Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels \\>100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T12/PR48', 'description': '12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG001', 'title': 'T12(DS)/PR48', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG002', 'title': 'Pbo/PR48', 'description': '48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 72', 'description': 'Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T12/PR48', 'description': '12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG001', 'title': 'T12(DS)/PR48', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG002', 'title': 'Pbo/PR48', 'description': '48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.40', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) to Week 4', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '132', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'T12/PR48', 'description': '12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG001', 'title': 'T12(DS)/PR48', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'OG002', 'title': 'Pbo/PR48', 'description': '48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 and Week 12', 'description': 'Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T12/PR48', 'description': '12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'FG001', 'title': 'T12(DS)/PR48', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'FG002', 'title': 'Pbo/PR48', 'description': '48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '266'}, {'groupId': 'FG001', 'numSubjects': '264'}, {'groupId': 'FG002', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '245'}, {'groupId': 'FG001', 'numSubjects': '248'}, {'groupId': 'FG002', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Subject Ineligible To Continue The Trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 105 sites in 17 countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Switzerland, Germany, Spain, France, United Kingdom, Israel, Italy, Netherlands, Poland, Sweden, and the United States.', 'preAssignmentDetails': '662 participants were treated (266 participants in the T12/PR48 group, 264 participants in the T12(DS)/PR48 group, and 132 participants in the Pbo/PR48 group) in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'BG000'}, {'value': '264', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '662', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'T12/PR48', 'description': '12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'BG001', 'title': 'T12(DS)/PR48', 'description': '4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'BG002', 'title': 'Pbo/PR48', 'description': '48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'spread': '8.51', 'groupId': 'BG000'}, {'value': '51', 'spread': '8.24', 'groupId': 'BG001'}, {'value': '49.9', 'spread': '9.74', 'groupId': 'BG002'}, {'value': '50.6', 'spread': '8.66', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '202', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '460', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '615', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'AgeCategoricalOther', 'classes': [{'title': '>= 45 years', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}, {'title': 'Between 45 and 65 years', 'categories': [{'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '483', 'groupId': 'BG003'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 663}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2008-06-19', 'resultsFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-18', 'studyFirstPostDateStruct': {'date': '2008-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned', 'timeFrame': 'Week 72', 'description': 'SVR24 planned is defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after the last planned dose of study medication.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4', 'timeFrame': 'Week 4', 'description': 'RVR was defined as having undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.'}, {'measure': 'Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment)', 'timeFrame': 'Week 48'}, {'measure': 'Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned', 'timeFrame': 'Week 60', 'description': 'SVR12 planned was defined as having undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks after the last planned dose of study medication (SVR12 planned).'}, {'measure': 'Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8', 'timeFrame': 'Week 4, Week 6, or Week 8', 'description': 'Telaprevir stopping rule is defined as having Hepatitis C virus (HCV) ribonucleic acid (RNA) levels \\>100 IU/mL at Week 4, Week 6, or Week 8 after start of telaprevir.'}, {'measure': 'Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72)', 'timeFrame': 'Up to Week 72', 'description': 'Viral relapse was defined as having confirmed detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels during entire follow-up period (up to Week 72).'}, {'measure': 'Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4', 'timeFrame': 'Baseline (Day 1) to Week 4'}, {'measure': 'Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12', 'timeFrame': 'Week 4 and Week 12', 'description': 'Extended rapid virologic response was defined as undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) levels.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis C, Chronic', 'Telaprevir', 'Peg-IFN-alfa-2a', 'Ribavirin'], 'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '24486089', 'type': 'DERIVED', 'citation': 'Zeuzem S, DeMasi R, Baldini A, Coate B, Luo D, Mrus J, Witek J. Risk factors predictive of anemia development during telaprevir plus peginterferon/ribavirin therapy in treatment-experienced patients. J Hepatol. 2014 Jun;60(6):1112-7. doi: 10.1016/j.jhep.2014.01.013. Epub 2014 Jan 29.'}, {'pmid': '24382638', 'type': 'DERIVED', 'citation': 'Younossi Z, Negro F, Serfaty L, Pol S, Diago M, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Focaccia R, Foster GR, Horban A, Lonjon-Domanec I, Coate B, DeMasi R, Picchio G, Witek J. Homeostasis model assessment of insulin resistance does not seem to predict response to telaprevir in chronic hepatitis C in the REALIZE trial. Hepatology. 2013 Dec;58(6):1897-906. doi: 10.1002/hep.26437. Epub 2013 Oct 17.'}, {'pmid': '23321318', 'type': 'DERIVED', 'citation': 'Pol S, Aerssens J, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Younossi Z, Foster GR, Focaccia R, Horban A, Pockros PJ, Van Heeswijk RP, De Meyer S, Luo D, Botfield M, Beumont M, Picchio G. Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure. J Hepatol. 2013 May;58(5):883-9. doi: 10.1016/j.jhep.2012.12.023. Epub 2013 Jan 12.'}, {'pmid': '21696308', 'type': 'DERIVED', 'citation': 'Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled Phase III trial with telaprevir in patients with chronic Hepatitis C Virus (HCV), genotype 1, infection who failed prior treatment with standard treatment. Standard treatment is defined as treatment with Peg-INF and RBV. The trial is designed to compare the efficacy, safety, and tolerability of 2 regimens of telaprevir (with and without delayed start) combined with standard treatment versus standard treatment alone. The trial will consist of a screening period of approximately 4 weeks, a 48-week treatment period, and a 24-week follow-up period. Patients will be eligible to enroll in the trial if they (1) had an undetectable HCV Ribonucleic Acid (RNA) level at the end of a prior course of standard treatment but did not achieve a response (viral relapsers), or (2) never had an undetectable HCV RNA level during or at the end of a prior course of standard treatment (non-responders). Approximately 650 patients (350 prior relapsers and 300 prior non-responders) will be randomized in a 2:2:1 ratio to one of 3 treatment groups: Treatment group A will receive telaprevir with standard treatment for 12 weeks; followed by placebo with standard treatment for 4 weeks; followed by standard treatment for 32 weeks. Treatment group B will receive placebo with standard treatment for 4 weeks; followed by telaprevir with standard treatment for 12 weeks; followed by standard treatment for 32 weeks. Treatment group C will receive placebo with standard treatment for 16 weeks; followed by standard treatment for 32 weeks. In both telaprevir regimens (A and B), patients will receive 12 weeks of 750 mg of telaprevir every 8 hours along with 48 weeks of standard treatment. Telaprevir or placebo will be given by mouth at a dose of 750 mg every 8 hours for 16 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV will be given by mouth at a dose of either 1000 or 1200 mg (depending on your body weight) two times per day for 48 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level \\>= 1000 IU/mL\n* Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)\n* Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication\n\nExclusion Criteria:\n\n* Patient is a previous non-responder that is classified as a viral breakthrough case\n* Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype\n* Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype\n* Evidence of decompensated liver disease\n* Patient has condition that requires use of systemic corticosteroids'}, 'identificationModule': {'nctId': 'NCT00703118', 'briefTitle': 'A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tibotec BVBA'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment', 'orgStudyIdInfo': {'id': 'CR014842'}, 'secondaryIdInfos': [{'id': 'VX-950-TIDP24-C216', 'type': 'OTHER', 'domain': 'Tibotec-Virco Virology BVBA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: T12/PR48', 'description': 'Participants will receive 12 weeks of 750 mg telaprevir eight hourly followed by 4 weeks of Placebo in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.', 'interventionNames': ['Drug: Telaprevir', 'Drug: Peg-IFN-alfa-2a', 'Drug: Ribavirin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: T12(DS)/PR48', 'description': 'Participants will receive 4 weeks of Placebo followed by 12 weeks of 750 mg telaprevir eight hourly in combination with 48 weeks of Peg-IFN-alfa-2a and ribavirin at standard doses.', 'interventionNames': ['Drug: Telaprevir', 'Drug: Peg-IFN-alfa-2a', 'Drug: Ribavirin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group C: Pbo/PR48', 'description': 'Participants will receive placebo in combination with Peg- IFN-alfa-2a and ribavirin for 16 weeks. Participants will receive Peg- IFN-alfa-2a and ribavirin for next 32 weeks.', 'interventionNames': ['Drug: Peg-IFN-alfa-2a', 'Drug: Ribavirin', 'Drug: Placebo']}], 'interventions': [{'name': 'Telaprevir', 'type': 'DRUG', 'description': 'Participants will receive telaprevir tablets of 750 mg orally eight hourly for 12 weeks in group A and B.', 'armGroupLabels': ['Group A: T12/PR48', 'Group B: T12(DS)/PR48']}, {'name': 'Peg-IFN-alfa-2a', 'type': 'DRUG', 'description': 'Participants will receive 180 µg subcutaneous (under the skin) injection of Peg-IFN-alfa-2a once weekly for 48 weeks in Group A, B and C.', 'armGroupLabels': ['Group A: T12/PR48', 'Group B: T12(DS)/PR48', 'Group C: Pbo/PR48']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'Participants will receive ribavirin tablets of 1000-1200 mg orally twice daily for 48 weeks in Group A, B, and C.', 'armGroupLabels': ['Group A: T12/PR48', 'Group B: T12(DS)/PR48', 'Group C: Pbo/PR48']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive telaprevir matching placebo tablets orally for 4 weeks in Group A and B. Participants will receive telaprevir matching placebo tablets orally for 16 weeks in Group C.', 'armGroupLabels': ['Group A: T12/PR48', 'Group B: T12(DS)/PR48', 'Group C: Pbo/PR48']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Coronado', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Bradenton', 'state': 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39.47391, 'lon': -0.37966}}, {'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Sankt Gallen', 'country': 'Switzerland', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'city': 'Zurich', 'country': 'Switzerland', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Tibotec-Virco Virology BVBA Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tibotec BVBA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tibotec BVBA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Tibotec Pharmaceutical Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}