Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-20 @ 11:51 AM
Study NCT ID:
NCT02582632
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2015-10-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'France', 'Germany', 'Israel', 'Italy', 'Spain', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C586094', 'term': 'ombitasvir'}, {'id': 'C585405', 'term': 'paritaprevir'}, {'id': 'C588260', 'term': 'dasabuvir'}]}}, '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': 'Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 12 weeks); serious adverse events (SAEs) were collected from the time informed consent was obtained (up to 35 days prior to first dose of study drug).', 'description': 'A TEAE is defined as any adverse event from the first dose of study drug to 30 days after the last dose.', 'eventGroups': [{'id': 'EG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks', 'otherNumAtRisk': 166, 'otherNumAffected': 70, 'seriousNumAtRisk': 166, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 35}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \\< lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug. Flanking imputation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-Treatment Virologic Failure During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 weeks while on treatment', 'description': 'On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA \\< LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements \\> 1 log\\^10 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 study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all enrolled participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Post-Treatment Relapse12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks after last dose of study drug', 'description': 'Relapse12 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 window) excluding reinfection among participants with HCV RNA \\< LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA \\< LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all enrolled participants who received at least 1 dose of study drug. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Female Participants Responding With SVR12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000', 'lowerLimit': '95.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as HCV RNA \\< LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all enrolled female participants who received at least 1 dose of study drug. Flanking imputation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as HCV RNA \\< LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all enrolled participants who received at least 1 dose of study drug and with baseline HCV RNA \\< 6,000,000 IU/mL. Flanking imputation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Who Achieve SVR12: mITT-GT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as HCV RNA \\< LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified ITT (mITT)-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Flanking imputation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 8 weeks while on treatment', 'description': 'On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA \\< LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements \\> 1 log\\^10 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 study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks after last dose of study drug', 'description': 'Relapse12 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 window) excluding reinfection among participants with HCV RNA \\< LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA \\< LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Female Participants Responding With SVR12: mITT-GT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as HCV RNA \\< LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; female participants. Flanking imputation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as HCV RNA \\< LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; participants with baseline HCV RNA \\< 6,000,000 IU/mL. Flanking imputation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily) and dasabuvir (250 mg twice daily) administered for 8 weeks'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '13.42', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-24'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2015-10-20', 'resultsFirstSubmitDate': '2017-11-16', 'studyFirstSubmitQcDate': '2015-10-20', 'lastUpdatePostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-16', 'studyFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants Who Achieve SVR12: mITT-GT Population', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as HCV RNA \\< LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.'}, {'measure': 'Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population', 'timeFrame': 'Up to 8 weeks while on treatment', 'description': 'On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA \\< LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements \\> 1 log\\^10 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 study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method.'}, {'measure': 'Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population', 'timeFrame': 'Up to 12 weeks after last dose of study drug', 'description': 'Relapse12 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 window) excluding reinfection among participants with HCV RNA \\< LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA \\< LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.'}, {'measure': 'Percentage of Female Participants Responding With SVR12: mITT-GT Population', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as HCV RNA \\< LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.'}, {'measure': 'Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population', 'timeFrame': 'Baseline and 12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as HCV RNA \\< LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) \\< lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With On-Treatment Virologic Failure During Treatment Period', 'timeFrame': 'Up to 8 weeks while on treatment', 'description': 'On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA \\< LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements \\> 1 log\\^10 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 study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution.'}, {'measure': 'Percentage of Participants With Post-Treatment Relapse12', 'timeFrame': 'Up to 12 weeks after last dose of study drug', 'description': 'Relapse12 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 window) excluding reinfection among participants with HCV RNA \\< LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA \\< LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.'}, {'measure': 'Percentage of Female Participants Responding With SVR12', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as HCV RNA \\< LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.'}, {'measure': 'Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12', 'timeFrame': 'Baseline and 12 weeks after the last actual dose of study drug', 'description': 'SVR12 is defined as HCV RNA \\< LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis C Virus', 'Interferon-Free', 'Ribavirin-Free', 'Hepatitis C', 'Hepatitis C Genotype 1b'], 'conditions': ['Hepatitis C Infection', 'Hepatitis C Virus']}, 'referencesModule': {'references': [{'pmid': '28416221', 'type': 'BACKGROUND', 'citation': 'Welzel TM, Asselah T, Dumas EO, Zeuzem S, Shaw D, Hazzan R, Forns X, Pilot-Matias T, Lu W, Cohen DE, Feld JJ. Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial. Lancet Gastroenterol Hepatol. 2017 Jul;2(7):494-500. doi: 10.1016/S2468-1253(17)30071-7. Epub 2017 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chronic HCV infection at Screening.\n2. Screening laboratory result indicating HCV genotype 1b infection.\n3. Treatment-naïve and non-cirrhotic.\n\nExclusion Criteria:\n\n1. HCV genotype or subtype other than GT1b.\n2. Positive test result for Hepatitis B surface antigen (HbsAg) or confirmed positive anti-HIV antibody (HIV Ab) test.\n3. Any current or past clinical evidence of cirrhosis.\n4. Screening laboratory analyses that shows abnormal results.\n5. Clinically significant abnormalities or co-morbidities, other than HCV infection that make the participant an unsuitable candidate for this study.'}, 'identificationModule': {'nctId': 'NCT02582632', 'acronym': 'GARNET', 'briefTitle': 'A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'An Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Adults With Genotype 1b Hepatitis C Virus (HCV) Without Cirrhosis (GARNET)', 'orgStudyIdInfo': {'id': 'M15-684'}, 'secondaryIdInfos': [{'id': '2015-003370-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir', 'description': 'Ombitasvir/Paritaprevir/Ritonavir(25 mg/150 mg/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 8 weeks', 'interventionNames': ['Drug: ombitasvir/paritaprevir/ritonavir', 'Drug: dasabuvir']}], 'interventions': [{'name': 'ombitasvir/paritaprevir/ritonavir', 'type': 'DRUG', 'otherNames': ['ABT-267/ABT-450/r', 'ombitasvir also known as ABT-267', 'paritaprevir also known as ABT-450'], 'description': 'Tablet', 'armGroupLabels': ['Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir']}, {'name': 'dasabuvir', 'type': 'DRUG', 'otherNames': ['ABT-333'], 'description': 'Tablet', 'armGroupLabels': ['Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Emily Dumas, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}