Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-31 @ 3:59 AM
Study NCT ID:
NCT01440595
Status:
TERMINATED
Last Update Posted:
2024-05-22
First Post:
2011-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy', 'Norway', 'United States']}, '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': 'C578009', 'term': 'grazoprevir'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'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': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Non-serious AEs were collected up to Week 26 and serious AEs (SAEs) were collected up to Week 48.', 'eventGroups': [{'id': 'EG000', 'title': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Irritabilty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Restless leg syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.'}], 'timeFrame': 'Week 12', 'description': 'cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.'}, {'type': 'SECONDARY', 'title': 'Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.'}], 'timeFrame': 'Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm', 'description': 'Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Rapid Viral Response (RVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.'}], 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.'}], 'timeFrame': 'Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm', 'description': 'SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.'}], 'timeFrame': 'Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm', 'description': 'SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.'}], 'timeFrame': 'Week 12', 'description': 'HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.'}], 'timeFrame': 'Week 24', 'description': 'cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Grazoprevir 200 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 200 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.'}, {'id': 'FG001', 'title': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.'}, {'id': 'FG002', 'title': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'No participants were randomized to the Grazoprevir 800 mg + Peg-IFN + RBV arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.5', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '51.0', 'spread': '0.0', 'groupId': 'BG001'}, {'value': '44.0', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Five participants were randomized as indicated in the Participant Flow Module, but only 3 participants were treated. Baseline Characteristics are presented only for treated participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Preliminary results of MK-5172 PN003 (NCT01353911) suggested a possible dose relationship to elevated transaminase levels in treatment with grazoprevir.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2012-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2011-09-22', 'resultsFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2011-09-22', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-03', 'studyFirstPostDateStruct': {'date': '2011-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms', 'timeFrame': 'Week 12', 'description': 'cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.'}], 'secondaryOutcomes': [{'measure': 'Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)', 'timeFrame': 'Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm', 'description': 'Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.'}, {'measure': 'Number of Participants Achieving Rapid Viral Response (RVR)', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.'}, {'measure': 'Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)', 'timeFrame': 'Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm', 'description': 'SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.'}, {'measure': 'Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)', 'timeFrame': 'Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm', 'description': 'SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.'}, {'measure': 'Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm', 'timeFrame': 'Week 12', 'description': 'HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.'}, {'measure': 'Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm', 'timeFrame': 'Week 24', 'description': 'cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=5172-012&kw=5172-012&tab=access', 'type': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered concomitantly with peg-interferon alfa-2b (Peg-IFN) and ribavirin (RBV) to treatment-naïve participants with chronic genotype 2 (GT2) or genotype 3 (GT3) hepatitis C virus (HCV) infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight ≥ 88 lbs and ≤ 275 lbs\n* Documented chronic Hepatitis C (CHC) GT2 or GT3 infection\n* No known cirrhosis\n* Agrees to use two acceptable methods of birth control during study and through 6 months after last dose of study drug\n* Chest X-ray within the last 6 months\n* Eye exam within the last 6 months\n\nExclusion Criteria:\n\n* Known to be human immunodeficiency virus (HIV) positive or co-infected with active hepatitis B virus (positive for Hepatitis B surface antigen)\n* Prior approved or investigational treatment for hepatitis C\n* Evidence of hepatocellular carcinoma\n* Diabetic and/or high blood pressure with clinically significant eye exam findings\n* Pre-existing psychiatric condition\n* Clinical diagnosis of abuse of certain substances within specified timeframes\n* Known medical condition that could interfere with participation\n* Active or suspected cancer within the last 5 years\n* Female who is pregnant, breastfeeding, or expecting to conceive or donate eggs\n* Male who is planning to impregnate partner or donate sperm\n* Male with a pregnant female partner\n* Chronic hepatitis not caused by HCV'}, 'identificationModule': {'nctId': 'NCT01440595', 'briefTitle': 'Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Partially Double-Blind, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly With Pegylated-Interferon and Ribavirin in Treatment-Naive Patients With Chronic Genotype 2 or 3 Hepatitis C Virus Infection', 'orgStudyIdInfo': {'id': '5172-012'}, 'secondaryIdInfos': [{'id': '2011-003299-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Grazoprevir 200 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 200 mg in combination with Peg-IFN and RBV for 12 weeks.', 'interventionNames': ['Drug: Grazoprevir', 'Drug: Peginterferon alfa-2b (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Grazoprevir 400 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 400 mg in combination with Peg-IFN and RBV for 12 weeks.', 'interventionNames': ['Drug: Grazoprevir', 'Drug: Peginterferon alfa-2b (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Peg-IFN + RBV', 'description': 'Placebo to grazoprevir in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.', 'interventionNames': ['Drug: Placebo to Grazoprevir', 'Drug: Peginterferon alfa-2b (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Grazoprevir 800 mg + Peg-IFN + RBV', 'description': 'Grazoprevir 800 mg in combination with Peg-IFN and RBV for 12 weeks.', 'interventionNames': ['Drug: Grazoprevir', 'Drug: Peginterferon alfa-2b (Peg-IFN)', 'Drug: Ribavirin (RBV)']}], 'interventions': [{'name': 'Grazoprevir', 'type': 'DRUG', 'otherNames': ['MK-5172'], 'description': 'Grazoprevir 100 mg tablets once daily for 12 weeks.', 'armGroupLabels': ['Grazoprevir 200 mg + Peg-IFN + RBV', 'Grazoprevir 400 mg + Peg-IFN + RBV', 'Grazoprevir 800 mg + Peg-IFN + RBV']}, {'name': 'Placebo to Grazoprevir', 'type': 'DRUG', 'description': 'Placebo to Grazoprevir once daily for 12 weeks', 'armGroupLabels': ['Placebo + Peg-IFN + RBV']}, {'name': 'Peginterferon alfa-2b (Peg-IFN)', 'type': 'DRUG', 'otherNames': ['PegIntron®, SCH 054031'], 'description': 'Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks', 'armGroupLabels': ['Grazoprevir 200 mg + Peg-IFN + RBV', 'Grazoprevir 400 mg + Peg-IFN + RBV', 'Grazoprevir 800 mg + Peg-IFN + RBV', 'Placebo + Peg-IFN + RBV']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['Rebetol®, SCH 018908'], 'description': 'Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks', 'armGroupLabels': ['Grazoprevir 200 mg + Peg-IFN + RBV', 'Grazoprevir 400 mg + Peg-IFN + RBV', 'Grazoprevir 800 mg + Peg-IFN + RBV', 'Placebo + Peg-IFN + RBV']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}