Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-29 @ 9:20 PM
Study NCT ID:
NCT01498068
Status:
COMPLETED
Last Update Posted:
2015-01-30
First Post:
2011-12-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, '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': '32 14 64 13 70', 'title': 'Compound Development Team Leader', 'organization': 'Janssen Belgium'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '60 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment-naïve', 'description': "Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.", 'otherNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment-experienced', 'description': "Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.", 'otherNumAtRisk': 20, 'otherNumAffected': 19, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Extended Rapid Virologic Response (eRVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naïve', 'description': "Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}, {'id': 'OG001', 'title': 'Treatment-experienced', 'description': "Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 and Week 12', 'description': 'A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis (FA) population: All participants who received at least one dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naïve', 'description': "Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}, {'id': 'OG001', 'title': 'Treatment-experienced', 'description': "Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}], 'classes': [{'title': 'Baseline (n=16, 20)', 'categories': [{'measurements': [{'value': '6.20', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '6.9'}, {'value': '6.10', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '7.0'}]}]}, {'title': 'Week 4 (n=16, 20)', 'categories': [{'measurements': [{'value': '-5.47', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '-3.9'}, {'value': '-5.33', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '-3.5'}]}]}, {'title': 'Week 8 (n=16,19)', 'categories': [{'measurements': [{'value': '-5.50', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '-3.9'}, {'value': '-5.39', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '-5.00'}]}]}, {'title': 'Week 12 (n=15,19)', 'categories': [{'measurements': [{'value': '-5.46', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '-3.9'}, {'value': '-5.39', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '-5.00'}]}]}, {'title': 'Week 24 (n=14, 19)', 'categories': [{'measurements': [{'value': '-5.53', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '-3.9'}, {'value': '-5.39', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '-0.6'}]}]}, {'title': 'Week 32 (n=2, 12)', 'categories': [{'measurements': [{'value': '-5.30', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '-5.1'}, {'value': '-5.46', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '-5.2'}]}]}, {'title': 'Week 40 (n=2, 12)', 'categories': [{'measurements': [{'value': '-5.30', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '-5.1'}, {'value': '-5.46', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '-5.2'}]}]}, {'title': 'Week 48 (n=2, 12)', 'categories': [{'measurements': [{'value': '-3.14', 'groupId': 'OG000', 'lowerLimit': '-5.1', 'upperLimit': '-1.2'}, {'value': '-5.46', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '-5.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48', 'description': 'Changes from baseline in log10 HCV RNA levels were calculated.', 'unitOfMeasure': 'Log 10 IU/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis (FA) population: All participants who received at least one dose of the study medication. "n" signifies number of participants who were evaluable at each specified timepoint for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Rapid Virologic Response (RVR) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naïve', 'description': "Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}, {'id': 'OG001', 'title': 'Treatment-experienced', 'description': "Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Week 4', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis (FA) population: All participants who received at least one dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naïve', 'description': "Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}, {'id': 'OG001', 'title': 'Treatment-experienced', 'description': "Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}], 'classes': [{'title': 'Week 8 (n=16, 20)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=16, 20)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=16, 20)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 32 (n=3, 14)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 40 (n=3, 14)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 (n=3, 14)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 8, 12, 24, 32, 40 and 48', 'description': 'The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naive and 14 Treatment-experienced participants were assigned to receive study treatment after Week 24. Only participants still receiving Treatment were assessed at 32, 40, and 48 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis (FA) population: All participants who received at least one dose of the study medication. "n" signifies number of participants who were evaluable at each specified timepoint for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naïve', 'description': "Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}, {'id': 'OG001', 'title': 'Treatment-experienced', 'description': "Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40', 'description': 'Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis (FA) population: All participants who received at least one dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each Specific Category of Treatment Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment-naïve', 'description': "Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}, {'id': 'OG001', 'title': 'Treatment-experienced', 'description': "Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}], 'classes': [{'title': 'SVR12', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Relapse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'On treatment virologic failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)', 'description': 'Participants were evaluated for following 4 categories of treatment outcome;Sustained Virologic Response 12 Weeks After Last Planned Dose of Study Medication(SVR12):hepatitis C virus (HCV)ribonucleic acid (RNA)\\<25 IU/mL(target not detected)12 weeks after last planned dose of study medication;Relapse:HCV RNA =\\>25 IU/mL during follow-up period after previous HCV RNA\\<25 IU/mL at planned end of treatment(EOT)\\[Week 24 or Week 48\\] and participant did not achieve SVR12planned;On treatment virologic failure:meeting virologic stopping rule and/or having detectable HCV RNA at EOT with viral breakthrough(having a confirmed increase \\>1 log 10 in HCV RNA level from the lowest level reached or confirmed value of HCV RNA \\>100 IU/mL in participants whose HCV RNA has previously become \\<25 IU/mL during treatment).Stopping rule defined as HCV RNA value \\>1000 IU/mL at Week 4, 8 or 12 or detectable HCV RNA at Week 24, 32 or 40;Other:HCV RNA \\<25 IU/mL at actual EOT and never HCV RNA =\\>25 IU/mL thereafter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis (FA) population: All participants who received at least one dose of the study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment-naïve', 'description': "Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}, {'id': 'FG001', 'title': 'Treatment-experienced', 'description': "Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 5 sites in Russia.', 'preAssignmentDetails': 'Of the 39 participants screened, 36 participants (16 treatment-naïve/ 20 treatment-experienced) were enrolled and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment-naïve', 'description': "Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}, {'id': 'BG001', 'title': 'Treatment-experienced', 'description': "Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<= 45 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Between 45 and 65 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': '> 65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-29', 'studyFirstSubmitDate': '2011-12-06', 'resultsFirstSubmitDate': '2013-09-11', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-08', 'studyFirstPostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Extended Rapid Virologic Response (eRVR)', 'timeFrame': 'Week 4 and Week 12', 'description': 'A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.'}], 'secondaryOutcomes': [{'measure': 'Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)', 'timeFrame': 'Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48', 'description': 'Changes from baseline in log10 HCV RNA levels were calculated.'}, {'measure': 'Number of Participants With Rapid Virologic Response (RVR) at Week 4', 'timeFrame': 'Week 4', 'description': 'A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Week 4'}, {'measure': 'Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48', 'timeFrame': 'Weeks 8, 12, 24, 32, 40 and 48', 'description': 'The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naive and 14 Treatment-experienced participants were assigned to receive study treatment after Week 24. Only participants still receiving Treatment were assessed at 32, 40, and 48 weeks.'}, {'measure': 'Number of Participants With Virologic Failure', 'timeFrame': 'Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40', 'description': 'Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40.'}, {'measure': 'Number of Participants in Each Specific Category of Treatment Outcome', 'timeFrame': 'From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)', 'description': 'Participants were evaluated for following 4 categories of treatment outcome;Sustained Virologic Response 12 Weeks After Last Planned Dose of Study Medication(SVR12):hepatitis C virus (HCV)ribonucleic acid (RNA)\\<25 IU/mL(target not detected)12 weeks after last planned dose of study medication;Relapse:HCV RNA =\\>25 IU/mL during follow-up period after previous HCV RNA\\<25 IU/mL at planned end of treatment(EOT)\\[Week 24 or Week 48\\] and participant did not achieve SVR12planned;On treatment virologic failure:meeting virologic stopping rule and/or having detectable HCV RNA at EOT with viral breakthrough(having a confirmed increase \\>1 log 10 in HCV RNA level from the lowest level reached or confirmed value of HCV RNA \\>100 IU/mL in participants whose HCV RNA has previously become \\<25 IU/mL during treatment).Stopping rule defined as HCV RNA value \\>1000 IU/mL at Week 4, 8 or 12 or detectable HCV RNA at Week 24, 32 or 40;Other:HCV RNA \\<25 IU/mL at actual EOT and never HCV RNA =\\>25 IU/mL thereafter.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Genotype 1 chronic Hepatitis C', 'VX-950HPC3007', 'VX-950', 'Hepatitis C', 'Telaprevir', 'HCV'], 'conditions': ['Genotype 1 Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced Russian participants with genotype 1 chronic hepatitis C.', 'detailedDescription': 'This is an open-label (all persons know the study drug assignment), multicenter study in treatment-naïve (participant did not receive any previous treatment for the treatment of hepatitis C) and treatment-experienced (participant did receive previous treatment for hepatitis C) Russian participants with genotype 1 chronic hepatitis C. After a screening period of approximately 4 weeks, participants will be treated for 12 weeks with telaprevir 750 mg every 8 hours in combination with Peg-IFN-alfa-2a and RBV followed by 12 or 36 weeks of treatment with Peg-IFN-alfa-2a and RBV alone depending on their liver disease status, response to previous treatment and individual virologic response during treatment in this study. After the treatment period, there is a follow-up phase of at least 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant has genotype 1 chronic hepatitis C with HCV RNA level \\>1000 IU/mL\n* Participant is either treatment-naïve and did not receive any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C, or participant is treatment-experienced who did not achieve sustained virologic response (SVR) 24 weeks after at least 1 prior course of Peg-IFN/RBV therapy (null-responder, partial-responder or viral relapse)\n* Participant must have documentation of liver biopsy or fibroscan within 2 years before the screening visit or agree to have a biopsy or fibroscan within the screening period unless histological cirrhosis was demonstrated by a biopsy or fibroscan \\> 2 years ago prior to screening\n* A female participant of childbearing potential and a nonvasectomized male participant who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female participant ) or 7 months (male participant) after the last dose of RBV\n\nExclusion Criteria:\n\n* Prior non-responder that is classified as a viral breakthrough participant\n* Participant is infected or co-infected with HCV of another genotype than genotype 1\n* Participant has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C\n* Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection\n* Participant has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma'}, 'identificationModule': {'nctId': 'NCT01498068', 'briefTitle': 'Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag International NV'}, 'officialTitle': 'Open-Label, Bridging Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Treatment- Naïve and Treatment-Experienced Russian Subjects With Genotype 1 Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'CR100676'}, 'secondaryIdInfos': [{'id': 'VX-950HPC3007', 'type': 'OTHER', 'domain': 'Janssen-Cilag International NV, Belgium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment-naïve', 'description': "Treatment naïve participants will receive telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual ontreatment virologic response in this study.", 'interventionNames': ['Drug: Telaprevir', 'Drug: Pegylated-interferon-alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment-experienced', 'description': "Treatment-experienced participants received telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.", 'interventionNames': ['Drug: Telaprevir', 'Drug: Pegylated-interferon-alfa-2a', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Telaprevir', 'type': 'DRUG', 'description': 'Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks', 'armGroupLabels': ['Treatment-experienced', 'Treatment-naïve']}, {'name': 'Pegylated-interferon-alfa-2a', 'type': 'DRUG', 'description': 'Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks', 'armGroupLabels': ['Treatment-experienced', 'Treatment-naïve']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': "Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is \\< 75kg) or 1200mg (if participant's weight is \\>= 75kg) per day for 24 or 48 weeks.", 'armGroupLabels': ['Treatment-experienced', 'Treatment-naïve']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Samara', 'country': 'Russia', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Smolensk', 'country': 'Russia', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'city': 'Stavropol', 'country': 'Russia', 'geoPoint': {'lat': 45.03442, 'lon': 41.9642}}], 'overallOfficials': [{'name': 'Janssen-Cilag International NV, Belgium Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag International NV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag International NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}