Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-04 @ 6:56 AM
Study NCT ID:
NCT01833533
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2013-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'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': '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': 'C588260', 'term': 'dasabuvir'}, {'id': 'C586094', 'term': 'ombitasvir'}, {'id': 'C585405', 'term': 'paritaprevir'}, {'id': 'C000607373', 'term': 'Viekira Pak'}, {'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': '800-633-9110', 'title': 'Global Medical Information', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 65 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks', 'otherNumAtRisk': 100, 'otherNumAffected': 81, 'seriousNumAtRisk': 100, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks', 'otherNumAtRisk': 205, 'otherNumAffected': 138, 'seriousNumAtRisk': 205, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 72}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 58}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'MEMORY IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'PANCREATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'DIVERTICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 205, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks'}, {'id': 'OG001', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000'}, {'value': '90.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '90.2', 'ciLowerLimit': '86.2', 'ciUpperLimit': '94.3', 'estimateComment': '95% CI was calculated using the normal approximation to the binomial distribution.', 'groupDescription': 'Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \\>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.'}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '97.0', 'ciLowerLimit': '93.7', 'ciUpperLimit': '100.0', 'estimateComment': '95% CI was calculated using the normal approximation to the binomial distribution.', 'groupDescription': 'Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \\>95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'The noninferiority of the rate of sustained virologic response at 12 weeks for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 65% to achieve noninferiority.'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after last dose of study drug', 'description': 'The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \\[HCV RNA\\] level less than the lower limit of quantitation \\[\\< LLOQ\\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.\n\nThe primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug (intent-to-treat \\[ITT\\] population); participants with missing data were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks'}, {'id': 'OG001', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000'}, {'value': '3.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) and Week 12 (End of Treatment)', 'description': 'The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to \\< LLN at the end of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks'}, {'id': 'OG001', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000'}, {'value': '90.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '97.0', 'ciLowerLimit': '93.7', 'ciUpperLimit': '100.0', 'estimateComment': '95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.', 'groupDescription': 'Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \\>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '90.2', 'ciLowerLimit': '86.2', 'ciUpperLimit': '94.3', 'estimateComment': '95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.', 'groupDescription': 'Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \\>90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (75%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.8', 'ciLowerLimit': '-12.0', 'ciUpperLimit': '-1.5', 'estimateComment': '95% CI was calculated using the normal approximation to the binomial distribution.', 'groupDescription': 'Based on a 2-sided significance level of 0.05 and an underlying rate of ≥90% in the ABT-450/r/ABT-267 and ABT-333, plus RBV arm (100 participants) and ≥85% in the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (200 participants) provides \\>95% power to demonstrate noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV arm compared with the ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV arm (normal approximation of a single binomial proportion in a one-sample test for superiority).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Noninferiority of the rate of sustained virologic response at 12 weeks after treatment in the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% CI (calculated using normal approximation to the binomial distribution)for the difference in percentage of participants must exceed -10.5% to achieve noninferiority.'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after last dose of study drug', 'description': 'The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation \\[\\< LLOQ\\]) 12 weeks after the last dose of study drug.\n\nThe secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Failure During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks'}, {'id': 'OG001', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks'}], 'classes': [{'title': 'Rebound', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Failure to suppress', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12', 'description': 'Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \\[≥ LLOQ\\] after HCV RNA \\< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \\[2 consecutive HCV RNA measurements \\> 1 log10 IU/mL above the lowest value post baseline\\] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \\[≥ 36 days\\] of treatment).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug (ITT population).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Relapse After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks'}, {'id': 'OG001', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '8.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)', 'description': 'Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (\\<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA \\< LLOQ at the final treatment visit and completed treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks'}, {'id': 'FG001', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '205'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '184'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'To Enter an Extension Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks'}, {'id': 'BG001', 'title': 'ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '10.99', 'groupId': 'BG000'}, {'value': '51.4', 'spread': '10.64', 'groupId': 'BG001'}, {'value': '51.5', 'spread': '10.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-08', 'studyFirstSubmitDate': '2013-02-27', 'resultsFirstSubmitDate': '2014-12-23', 'studyFirstSubmitQcDate': '2013-04-13', 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-23', 'studyFirstPostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses', 'timeFrame': '12 weeks after last dose of study drug', 'description': 'The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \\[HCV RNA\\] level less than the lower limit of quantitation \\[\\< LLOQ\\]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.\n\nThe primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment', 'timeFrame': 'Baseline (Day 1) and Week 12 (End of Treatment)', 'description': 'The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to \\< LLN at the end of treatment.'}, {'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses', 'timeFrame': '12 weeks after last dose of study drug', 'description': 'The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation \\[\\< LLOQ\\]) 12 weeks after the last dose of study drug.\n\nThe secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.'}, {'measure': 'Percentage of Participants With Virologic Failure During Treatment', 'timeFrame': 'Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12', 'description': 'Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \\[≥ LLOQ\\] after HCV RNA \\< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \\[2 consecutive HCV RNA measurements \\> 1 log10 IU/mL above the lowest value post baseline\\] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks \\[≥ 36 days\\] of treatment).'}, {'measure': 'Percentage of Participants With Virologic Relapse After Treatment', 'timeFrame': 'Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)', 'description': 'Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (\\<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Hepatitis C', 'Hepatitis C Virus', 'Hepatitis C Genotype 1a', 'Hepatitis C', 'Treatment-Naïve', 'Interferon-Free', 'Paritaprevir', 'Ombitasvir', 'Dasabuvir', 'Ribavirin', 'Viekira PAK'], 'conditions': ['Chronic Hepatitis C Infection']}, 'referencesModule': {'references': [{'pmid': '24795200', 'type': 'BACKGROUND', 'citation': 'Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR; PEARL-III Study; PEARL-IV Study. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014 May 22;370(21):1983-92. doi: 10.1056/NEJMoa1402338. Epub 2014 May 4.'}, {'pmid': '29377566', 'type': 'DERIVED', 'citation': 'Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.', 'detailedDescription': 'A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naive, noncirrhotic participants with chronic hepatitis C virus genotype 1a (HCV GT1a) infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile\n* Chronic hepatitis C, genotype 1a-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)\n* Subject has never received antiviral treatment for hepatitis C infection\n* No evidence of liver cirrhosis\n\nExclusion Criteria:\n\n* Significant liver disease with any cause other than HCV as the primary cause\n* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody\n* Positive screen for drugs or alcohol\n* Significant sensitivity to any drug\n* Use of contraindicated medications within 2 weeks of dosing\n* Abnormal laboratory tests'}, 'identificationModule': {'nctId': 'NCT01833533', 'acronym': 'PEARL-IV', 'briefTitle': 'A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection (PEARL-IV)', 'orgStudyIdInfo': {'id': 'M14-002'}, 'secondaryIdInfos': [{'id': '2012-005522-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABT-450/r/ABT-267 and ABT-333, Plus RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks', 'interventionNames': ['Drug: ABT-450/r/ABT-267, ABT-333', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV', 'description': 'ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks', 'interventionNames': ['Drug: ABT-450/r/ABT-267, ABT-333', 'Drug: Placebo for Ribavirin']}], 'interventions': [{'name': 'ABT-450/r/ABT-267, ABT-333', 'type': 'DRUG', 'otherNames': ['ABT-267 also known as ombitasvir', 'ABT-450 also known as paritaprevir', 'ABT-333 also known as dasabuvir', 'Viekira PAK'], 'description': 'Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet', 'armGroupLabels': ['ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV', 'ABT-450/r/ABT-267 and ABT-333, Plus RBV']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'Capsule', 'armGroupLabels': ['ABT-450/r/ABT-267 and ABT-333, Plus RBV']}, {'name': 'Placebo for Ribavirin', 'type': 'DRUG', 'description': 'Capsule', 'armGroupLabels': ['ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yan Luo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}