Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT01183169
Status:
COMPLETED
Last Update Posted:
2016-08-25
First Post:
2010-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], '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'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'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': 'C499715', 'term': 'alisporivir'}, {'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': {'email': 'info-international@debiopharm.com', 'phone': '4121 321 01 11', 'title': 'Vice President Clinical Research & Development', 'organization': 'Debiopharm International S.A.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'In April 2012, ALV and placebo were discontinued in all participants. Participants remained on PEG and RBV treatment.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment A: On-treatment AEs', 'description': 'Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.', 'otherNumAtRisk': 120, 'otherNumAffected': 116, 'seriousNumAtRisk': 120, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Treatment B: On-treatment AEs', 'description': 'AEs occurring while on treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.', 'otherNumAtRisk': 115, 'otherNumAffected': 108, 'seriousNumAtRisk': 115, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Treatment C1: On-treatment AEs', 'description': 'AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.', 'otherNumAtRisk': 59, 'otherNumAffected': 58, 'seriousNumAtRisk': 59, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Treatment C2: On-treatment AEs', 'description': 'AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.', 'otherNumAtRisk': 55, 'otherNumAffected': 54, 'seriousNumAtRisk': 55, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Treatment D: On-treatment AEs', 'description': 'AEs occurring while on treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.', 'otherNumAtRisk': 108, 'otherNumAffected': 106, 'seriousNumAtRisk': 108, 'seriousNumAffected': 18}, {'id': 'EG005', 'title': 'Treatment A: Post-treatment AEs', 'description': 'AEs occurring after end of treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.', 'otherNumAtRisk': 120, 'otherNumAffected': 22, 'seriousNumAtRisk': 120, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Treatment B: Post-treatment AEs', 'description': 'AEs occurring after end of treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.', 'otherNumAtRisk': 115, 'otherNumAffected': 21, 'seriousNumAtRisk': 115, 'seriousNumAffected': 4}, {'id': 'EG007', 'title': 'Treatment C1: Post-treatment AEs', 'description': 'AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.', 'otherNumAtRisk': 59, 'otherNumAffected': 13, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Treatment C2: Post-treatment AEs', 'description': 'AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.', 'otherNumAtRisk': 55, 'otherNumAffected': 10, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Treatment D: Post-treatment AEs', 'description': 'AEs occurring after end of treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.', 'otherNumAtRisk': 108, 'otherNumAffected': 19, 'seriousNumAtRisk': 108, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 51}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 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'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, 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'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 14}, {'groupId': 'EG005', 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'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 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'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, 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{'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 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59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 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Post-switch groups were assessed 12 weeks after the switch.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) For Efficacy, defined as all randomized participants who were randomized after the 2nd protocol amendment'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'ALV 600 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'OG004', 'title': 'Treatment C1A', 'description': 'ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.'}, {'id': 'OG005', 'title': 'Treatment C2A', 'description': 'ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}, {'value': '20.9', 'groupId': 'OG002'}, {'value': '58.7', 'groupId': 'OG003'}, {'value': '39.4', 'groupId': 'OG004'}, {'value': '73.3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 12 weeks of treatment', 'description': 'cEVR-LOD was defined as serum HCV RNA below the limit of detection (\\< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS For Efficacy'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'ALV 600 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'OG004', 'title': 'Treatment C1A', 'description': 'ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.'}, {'id': 'OG005', 'title': 'Treatment C2A', 'description': 'ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.'}], 'classes': [{'title': 'SVR12-LOQ', 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000'}, {'value': '51.9', 'groupId': 'OG001'}, {'value': '14.5', 'groupId': 'OG002'}, {'value': '65.1', 'groupId': 'OG003'}, {'value': '18.2', 'groupId': 'OG004'}, {'value': '53.3', 'groupId': 'OG005'}]}]}, {'title': 'SVR12-LOD', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}, {'value': '50.9', 'groupId': 'OG001'}, {'value': '14.5', 'groupId': 'OG002'}, {'value': '63.3', 'groupId': 'OG003'}, {'value': '18.2', 'groupId': 'OG004'}, {'value': '53.3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after treatment', 'description': 'SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA \\< LOQ and serum HCV RNA \\< LOD 12 weeks after treatment, respectively.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS For Efficacy'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'ALV 600 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'OG004', 'title': 'Treatment C1A', 'description': 'ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.'}, {'id': 'OG005', 'title': 'Treatment C2A', 'description': 'ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.'}], 'classes': [{'title': 'SVR24-LOQ', 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '51.9', 'groupId': 'OG001'}, {'value': '14.5', 'groupId': 'OG002'}, {'value': '65.1', 'groupId': 'OG003'}, {'value': '18.2', 'groupId': 'OG004'}, {'value': '53.3', 'groupId': 'OG005'}]}]}, {'title': 'SVR24-LOD', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '14.5', 'groupId': 'OG002'}, {'value': '63.3', 'groupId': 'OG003'}, {'value': '18.2', 'groupId': 'OG004'}, {'value': '53.3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after treatment', 'description': 'SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA \\< LOQ and serum HCV RNA \\< LOD 24 weeks after treatment, respectively.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS For Efficacy'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'ALV 600 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'OG004', 'title': 'Treatment C1A', 'description': 'ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.'}, {'id': 'OG005', 'title': 'Treatment C2A', 'description': 'ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.'}], 'classes': [{'title': 'RVR-LOQ', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '7.3', 'groupId': 'OG002'}, {'value': '41.3', 'groupId': 'OG003'}, {'value': '39.4', 'groupId': 'OG004'}, {'value': '56.7', 'groupId': 'OG005'}]}]}, {'title': 'RVR-LOD', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}, {'value': '22.9', 'groupId': 'OG003'}, {'value': '18.2', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 4 weeks of treatment', 'description': 'RVR-LOQ and RVR-LOD were defined as serum HCV RNA \\< LOQ and serum HCV RNA \\< LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS For Efficacy'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'ALV 600 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'OG004', 'title': 'Treatment C1A', 'description': 'ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.'}, {'id': 'OG005', 'title': 'Treatment C2A', 'description': 'ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.'}], 'classes': [{'title': 'pEVR-LOQ', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000'}, {'value': '28.7', 'groupId': 'OG001'}, {'value': '31.8', 'groupId': 'OG002'}, {'value': '11.9', 'groupId': 'OG003'}, {'value': '3.0', 'groupId': 'OG004'}, {'value': '6.7', 'groupId': 'OG005'}]}]}, {'title': 'pEVR-LOD', 'categories': [{'measurements': [{'value': '47.3', 'groupId': 'OG000'}, {'value': '48.1', 'groupId': 'OG001'}, {'value': '46.4', 'groupId': 'OG002'}, {'value': '27.5', 'groupId': 'OG003'}, {'value': '9.1', 'groupId': 'OG004'}, {'value': '13.3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 12 weeks of treatment', 'description': 'pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS For Efficacy'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'ALV 600 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'OG004', 'title': 'Treatment C1A', 'description': 'ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.'}, {'id': 'OG005', 'title': 'Treatment C2A', 'description': 'ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.'}], 'classes': [{'title': 'ETR-LOQ', 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000'}, {'value': '74.1', 'groupId': 'OG001'}, {'value': '33.6', 'groupId': 'OG002'}, {'value': '82.6', 'groupId': 'OG003'}, {'value': '51.5', 'groupId': 'OG004'}, {'value': '73.3', 'groupId': 'OG005'}]}]}, {'title': 'ETR-LOD', 'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000'}, {'value': '70.4', 'groupId': 'OG001'}, {'value': '31.8', 'groupId': 'OG002'}, {'value': '78.9', 'groupId': 'OG003'}, {'value': '36.4', 'groupId': 'OG004'}, {'value': '66.7', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 48 weeks', 'description': 'ETR-LOQ and ETR-LOD were defined as serum HCV RNA \\< LOQ and serum HCV RNA \\< LOD at treatment end (completed or prematurely discontinued), respectively.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS For Efficacy'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'ALV 600 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'OG004', 'title': 'Treatment C1A', 'description': 'ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.'}, {'id': 'OG005', 'title': 'Treatment C2A', 'description': 'ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.'}], 'classes': [{'title': 'End of Treatment (n = 53,49,60,53,14,7)', 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000'}, {'value': '77.6', 'groupId': 'OG001'}, {'value': '59.0', 'groupId': 'OG002'}, {'value': '83.0', 'groupId': 'OG003'}, {'value': '35.7', 'groupId': 'OG004'}, {'value': '28.6', 'groupId': 'OG005'}]}]}, {'title': 'End of Study (n = 49,42,18,46,13,6)', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '61.2', 'groupId': 'OG001'}, {'value': '18.0', 'groupId': 'OG002'}, {'value': '67.9', 'groupId': 'OG003'}, {'value': '21.4', 'groupId': 'OG004'}, {'value': '28.6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the FAS For Efficacy with abnormal ALT at baseline and available data at the respective time point'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-treatment Viral Breakthrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'ALV 600 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'OG004', 'title': 'Treatment C1A', 'description': 'ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.'}, {'id': 'OG005', 'title': 'Treatment C2A', 'description': 'ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}, {'value': '5.5', 'groupId': 'OG002'}, {'value': '2.8', 'groupId': 'OG003'}, {'value': '6.1', 'groupId': 'OG004'}, {'value': '10.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 48 weeks', 'description': 'On-treatment viral breakthrough was defined as either:\n\n* Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or\n* HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\\< LOQ) during treatment', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS For Efficacy'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Viral Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'ALV 600 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'OG004', 'title': 'Treatment C1A', 'description': 'ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.'}, {'id': 'OG005', 'title': 'Treatment C2A', 'description': 'ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}, {'value': '17.3', 'groupId': 'OG002'}, {'value': '12.8', 'groupId': 'OG003'}, {'value': '30.3', 'groupId': 'OG004'}, {'value': '13.3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 24 weeks after treatment', 'description': 'Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (\\< LOQ) during treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS For Efficacy'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment A', 'description': 'Alisporivir (ALV; DEB025) 600 mg once daily (QD) with peginterferon alfa-2a (PEG) and ribavirin (RBV) for up to 48 weeks.'}, {'id': 'FG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'FG002', 'title': 'Treatment C1', 'description': 'Treatment C subset C1: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR: hepatitis C virus (HCV) ribonucleic acid (RNA) \\<LOQ after 12 weeks of treatment) could switch to active ALV 600 mg QD with PEG and RBV.'}, {'id': 'FG003', 'title': 'Treatment C2', 'description': 'Treatment C subset C2: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV 400 mg twice daily (BID) with PEG and RBV.'}, {'id': 'FG004', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'FG005', 'title': 'Treatment C1A', 'description': 'ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.'}, {'id': 'FG006', 'title': 'Treatment C2A', 'description': 'ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.'}], 'periods': [{'title': 'Main Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '109'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Completed Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '77'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Switched to ALV', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '83'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '26'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Post-switch Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Not a post-switch group', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Not a post-switch group', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Not a post-switch group', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Not a post-switch group', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Not a post-switch group', 'groupId': 'FG004', 'numSubjects': '0'}, {'comment': 'Participants in Treatment C1 who switched to active ALV', 'groupId': 'FG005', 'numSubjects': '35'}, {'comment': 'Participants in Treatment C2 who switched to active ALV', 'groupId': 'FG006', 'numSubjects': '30'}]}, {'type': 'Completed Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '21'}, {'groupId': 'FG006', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}, {'value': '459', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment A', 'description': 'ALV 600 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'BG001', 'title': 'Treatment B', 'description': 'ALV 800 mg QD with PEG and RBV for up to 48 weeks.'}, {'id': 'BG002', 'title': 'Treatment C', 'description': 'Treatment C1 + Treatment C2. ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.'}, {'id': 'BG003', 'title': 'Treatment D', 'description': 'ALV 400 mg BID with PEG and RBV for up to 48 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.2', 'spread': '9.24', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '10.11', 'groupId': 'BG001'}, {'value': '50.5', 'spread': '10.50', 'groupId': 'BG002'}, {'value': '51.0', 'spread': '9.68', 'groupId': 'BG003'}, {'value': '50.6', 'spread': '9.86', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '181', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '278', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 459}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-14', 'studyFirstSubmitDate': '2010-08-16', 'resultsFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2010-08-16', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-14', 'studyFirstPostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)', 'timeFrame': 'after 12 weeks of treatment', 'description': 'cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)', 'timeFrame': 'after 12 weeks of treatment', 'description': 'cEVR-LOD was defined as serum HCV RNA below the limit of detection (\\< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.'}, {'measure': 'Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD', 'timeFrame': '12 weeks after treatment', 'description': 'SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA \\< LOQ and serum HCV RNA \\< LOD 12 weeks after treatment, respectively.'}, {'measure': 'Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD', 'timeFrame': '24 weeks after treatment', 'description': 'SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA \\< LOQ and serum HCV RNA \\< LOD 24 weeks after treatment, respectively.'}, {'measure': 'Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD', 'timeFrame': 'after 4 weeks of treatment', 'description': 'RVR-LOQ and RVR-LOD were defined as serum HCV RNA \\< LOQ and serum HCV RNA \\< LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.'}, {'measure': 'Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD', 'timeFrame': 'after 12 weeks of treatment', 'description': 'pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.'}, {'measure': 'Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD', 'timeFrame': 'within 48 weeks', 'description': 'ETR-LOQ and ETR-LOD were defined as serum HCV RNA \\< LOQ and serum HCV RNA \\< LOD at treatment end (completed or prematurely discontinued), respectively.'}, {'measure': 'Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Percentage of Participants With On-treatment Viral Breakthrough', 'timeFrame': 'within 48 weeks', 'description': 'On-treatment viral breakthrough was defined as either:\n\n* Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or\n* HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\\< LOQ) during treatment'}, {'measure': 'Percentage of Participants With Viral Relapse', 'timeFrame': 'within 24 weeks after treatment', 'description': 'Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (\\< LOQ) during treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic hepatitis C', 'Cyclophilin inhibitor'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Chronic HCV genotype 1 viral infection\n* HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening\n* Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks\n\nExclusion criteria:\n\n* Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening\n* Women of child-bearing potential unless using highly effective\n* Any other cause of relevant liver disease other than HCV\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01183169', 'briefTitle': 'Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment', 'orgStudyIdInfo': {'id': 'CDEB025A2210'}, 'secondaryIdInfos': [{'id': '2010-020033-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: ALV 600 mg QD', 'description': 'Alisporivir (ALV) 600 mg once daily (QD) with Peginterferon alfa-2a (PEG) and Ribavirin (RBV) for up to 48 weeks', 'interventionNames': ['Drug: Alisporivir', 'Drug: Peginterferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: ALV 800 mg QD', 'description': 'Alisporivir (ALV) 800 mg QD with PEG and RBV for up to 48 weeks', 'interventionNames': ['Drug: Alisporivir', 'Drug: Peginterferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C1: ALV Placebo - 600 mg QD', 'description': 'ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR) after 12 weeks of treatment may switch to active ALV 600 mg QD with PEG and RBV.', 'interventionNames': ['Drug: Alisporivir', 'Drug: Peginterferon alfa-2a', 'Drug: Ribavirin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C2: ALV Placebo - 400 mg BID', 'description': 'ALV Placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR after 12 weeks of treatment may switch to active ALV 400 mg twice daily (BID) with PEG and RBV.', 'interventionNames': ['Drug: Alisporivir', 'Drug: Peginterferon alfa-2a', 'Drug: Ribavirin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D: ALV 400 mg BID', 'description': 'Alisporivir (ALV) 400 mg twice daily BID with PEG and RBV for up to 48 weeks', 'interventionNames': ['Drug: Alisporivir', 'Drug: Peginterferon alfa-2a', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Alisporivir', 'type': 'DRUG', 'otherNames': ['DEB025', 'ALV'], 'description': 'ALV 200 mg soft gel 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