Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-01-07 @ 8:38 PM
Study NCT ID:
NCT02219503
Status:
COMPLETED
Last Update Posted:
2021-07-12
First Post:
2014-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Canada', 'United States']}, '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': 'C586094', 'term': 'ombitasvir'}, {'id': 'C585405', 'term': 'paritaprevir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'C588260', 'term': 'dasabuvir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', '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 and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 42 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir', 'description': 'Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.', 'otherNumAtRisk': 60, 'otherNumAffected': 39, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'PRURITUS GENERALISED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}], 'seriousEvents': [{'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir', 'description': 'Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '94.0', 'ciUpperLimit': '100.0', 'estimateComment': '95% confidence interval (CI) was calculated using Wilson score method.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': "The non-inferiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Non-inferiority was to be declared if the lower confidence bound was greater than 72.7%."}, {'groupIds': ['OG000'], 'paramType': 'Percentage of Participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100', 'ciLowerLimit': '94.0', 'ciUpperLimit': '100.0', 'estimateComment': '95% confidence interval (CI) was calculated using Wilson score method.', 'groupDescription': "The superiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Superiority was declared if the lower confidence bound was greater than 83.2%.", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Post-treatment Day 1 to Post-treatment Week 12', 'description': 'Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\\< LLOQ; \\< 25 IU/mL) 12 weeks after the last dose of study drug.\n\nThe primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-Treatment Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir', 'description': 'Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Week 12', 'description': 'On-Treatment Virologic Failure is defined as confirmed HCV RNA \\>= LLOQ after HCV RNA \\< LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA \\[2 consecutive HCV RNA measurements \\> 1 log10 IU/mL above nadir\\] at any time point during treatment, or failure to suppress during treatment \\[all on-treatment values of HCV RNA \\>= LLOQ\\] with at least 6 weeks \\[defined as active study drug duration ≥ 36 days\\] of treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Post-Treatment Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir', 'description': 'Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-treatment Day 1 to Post-treatment Week 12', 'description': 'Post- Treatment Relapse is defined as confirmed HCV RNA \\>= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug \\[up to and including the SVR12 assessment time point\\] for a participant with HCV RNA \\< LLOQ at Final Treatment Visit who completes treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir', 'description': 'Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 60 subjects were enrolled and all the subjects completed the study. All 60 subjects were analyzed for both efficacy (included all participants who received at least 1 dose of study drug (ITT)) and safety.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir', 'description': 'Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.5', 'spread': '9.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Interleukin 28B (IL28B) Genotype', 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'CT', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}, {'title': 'TT', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline analyses included all participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-08', 'studyFirstSubmitDate': '2014-08-15', 'resultsFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2014-08-15', 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-23', 'studyFirstPostDateStruct': {'date': '2014-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment', 'timeFrame': 'Post-treatment Day 1 to Post-treatment Week 12', 'description': 'Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (\\< LLOQ; \\< 25 IU/mL) 12 weeks after the last dose of study drug.\n\nThe primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With On-Treatment Virologic Failure', 'timeFrame': 'Day 1 through Week 12', 'description': 'On-Treatment Virologic Failure is defined as confirmed HCV RNA \\>= LLOQ after HCV RNA \\< LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA \\[2 consecutive HCV RNA measurements \\> 1 log10 IU/mL above nadir\\] at any time point during treatment, or failure to suppress during treatment \\[all on-treatment values of HCV RNA \\>= LLOQ\\] with at least 6 weeks \\[defined as active study drug duration ≥ 36 days\\] of treatment.'}, {'measure': 'Percentage of Participants With Post-Treatment Relapse', 'timeFrame': 'Post-treatment Day 1 to Post-treatment Week 12', 'description': 'Post- Treatment Relapse is defined as confirmed HCV RNA \\>= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug \\[up to and including the SVR12 assessment time point\\] for a participant with HCV RNA \\< LLOQ at Final Treatment Visit who completes treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis C', 'Chronic Hepatitis C', 'Compensated Cirrhosis', 'Cirrhotic', 'Hepatitis C Genotype 1b', 'Hepatitis C Virus', 'Interferon-Free', 'Child Pugh A', 'Ribavirin-Free'], 'conditions': ['Chronic Hepatitis C Infection', 'Compensated Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '26476290', 'type': 'BACKGROUND', 'citation': 'Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashab M, Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally AR, Pangerl A, Shulman NS, Poordad F. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016 Feb;64(2):301-307. doi: 10.1016/j.jhep.2015.10.005. Epub 2015 Oct 22.'}], 'seeAlsoLinks': [{'url': 'http://www.rxabbvie.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.', 'detailedDescription': 'This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:\n\n * Positive for anti-HCV antibody (Ab) or HCV RNA \\> 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or\n * HCV RNA \\> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).\n2. Screening laboratory result indicating HCV genotype 1b-infection.\n3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding.\n2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).\n3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.\n4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)\n5. Use of contraindicated medications within 2 weeks of dosing\n6. Screening laboratory analyses showing any of the following abnormal laboratory results:\n\n * Calculated creatinine clearance (using Cockcroft-Gault method) \\< 30 mL/min\n * Albumin \\< 2.8 g/dL\n * International normalized ratio (INR) \\> 1.8. Participants with a known inherited blood disorder and INR \\> 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.\n * Hemoglobin \\< 10 g/dL\n * Platelets \\< 25,000 cells per mm3\n * Total bilirubin \\> 3.0 mg/dL'}, 'identificationModule': {'nctId': 'NCT02219503', 'acronym': 'TURQUOISE-III', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)', 'orgStudyIdInfo': {'id': 'M14-490'}, 'secondaryIdInfos': [{'id': '2014-001953-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir', 'description': 'Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks', 'interventionNames': ['Drug: Ombitasvir/Paritaprevir/Ritonavir', 'Drug: Dasabuvir']}], 'interventions': [{'name': 'Ombitasvir/Paritaprevir/Ritonavir', 'type': 'DRUG', 'otherNames': ['ABT-267 also known as ombitasvir', 'ABT-450 also known as paritaprevir', 'Ritonavir also known as norvir'], 'description': 'Tablet; paritaprevir co-formulated with ritonavir and ombitasvir', 'armGroupLabels': ['Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir']}, {'name': 'Dasabuvir', 'type': 'DRUG', 'otherNames': ['ABT-333'], 'description': 'Tablet', 'armGroupLabels': ['Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Roger Trinh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}