Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-29 @ 10:45 PM
Study NCT ID:
NCT02609659
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'C588260', 'term': 'dasabuvir'}, {'id': 'C000607373', 'term': 'Viekira Pak'}, {'id': 'C585405', 'term': 'paritaprevir'}, {'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 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) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks).', 'description': 'TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': '3-DAA + RBV 600 mg', 'description': '3-DAA (ombitasvir/paritaprevir/ritonavir \\[25 mg/150 mg/100 mg once daily\\] and dasabuvir \\[250 mg twice daily\\]) plus RBV (ribavirin \\[600 mg once daily\\]) for 12 weeks.', 'otherNumAtRisk': 105, 'otherNumAffected': 53, 'seriousNumAtRisk': 105, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'CYCLIC VOMITING SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'BIPOLAR I DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3-DAA + RBV 600 mg', 'description': '3-DAA (ombitasvir/paritaprevir/ritonavir \\[25 mg/150 mg/100 mg once daily\\] and dasabuvir \\[250 mg twice daily\\]) plus RBV (ribavirin \\[600 mg once daily\\]) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '83.7', 'upperLimit': '95.4'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '89.5', 'ciLowerLimit': '83.7', 'ciUpperLimit': '95.4', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the 3-DAA + RBV 600 mg treatment group as compared with the historical rate for 3-DAA + weight-based 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 92% to achieve noninferiority.'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \\[\\<LLOQ\\]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after flanking imputation were counted as nonresponders.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Hemoglobin < 10 g/dL During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3-DAA + RBV 600 mg', 'description': '3-DAA (ombitasvir/paritaprevir/ritonavir \\[25 mg/150 mg/100 mg once daily\\] and dasabuvir \\[250 mg twice daily\\]) plus RBV (ribavirin \\[600 mg once daily\\]) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 weeks', 'description': 'The percentage of participants with hemoglobin \\<10 g/dL during treatment is provided.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug (ITT population) with at least one post-baseline hemoglobin value through the final treatment value.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Hemoglobin Values From Baseline to End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3-DAA + RBV 600 mg', 'description': '3-DAA (ombitasvir/paritaprevir/ritonavir \\[25 mg/150 mg/100 mg once daily\\] and dasabuvir \\[250 mg twice daily\\]) plus RBV (ribavirin \\[600 mg once daily\\]) for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '8.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.9', 'spread': '9.37', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.2', 'spread': '9.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.4', 'spread': '10.06', 'groupId': 'OG000'}]}]}, {'title': 'Final Treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.1', 'spread': '9.90', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)', 'description': 'The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug (ITT population) with a hemoglobin value at baseline and at given timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-treatment Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3-DAA + RBV 600 mg', 'description': '3-DAA (ombitasvir/paritaprevir/ritonavir \\[25 mg/150 mg/100 mg once daily\\] and dasabuvir \\[250 mg twice daily\\]) plus RBV (ribavirin \\[600 mg once daily\\]) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks', 'description': 'On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \\< LLOQ during treatment; confirmed increase of \\> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug (ITT population).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Post-treatment Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3-DAA + RBV 600 mg', 'description': '3-DAA (ombitasvir/paritaprevir/ritonavir \\[25 mg/150 mg/100 mg once daily\\] and dasabuvir \\[250 mg twice daily\\]) plus RBV (ribavirin \\[600 mg once daily\\]) for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the end of treatment through 12 weeks after the last dose of study drug', 'description': 'Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug, excluding reinfection, among participants who completed treatment with HCV RNA levels \\< LLOQ at the end of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA \\<LLOQ at the final treatment visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3-DAA + RBV 600 mg', 'description': '3-DAA (ombitasvir/paritaprevir/ritonavir \\[25 mg/150 mg/100 mg once daily\\] and dasabuvir \\[250 mg twice daily\\]) plus RBV (ribavirin \\[600 mg once daily\\]) for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '3-DAA + RBV 600 mg', 'description': '3-DAA (ombitasvir/paritaprevir/ritonavir \\[25 mg/150 mg/100 mg once daily\\] and dasabuvir \\[250 mg twice daily\\]) plus RBV (ribavirin \\[600 mg once daily\\]) for 12 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'spread': '13.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-27', 'studyFirstSubmitDate': '2015-11-18', 'resultsFirstSubmitDate': '2017-09-21', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-21', 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)', 'timeFrame': '12 weeks after the last actual dose of study drug', 'description': 'SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \\[\\<LLOQ\\]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.'}, {'measure': 'Percentage of Participants With Hemoglobin < 10 g/dL During Treatment', 'timeFrame': 'up to 12 weeks', 'description': 'The percentage of participants with hemoglobin \\<10 g/dL during treatment is provided.'}, {'measure': 'Mean Change in Hemoglobin Values From Baseline to End of Treatment', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)', 'description': 'The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With On-treatment Virologic Failure', 'timeFrame': 'Up to 12 weeks', 'description': 'On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA \\< LLOQ during treatment; confirmed increase of \\> 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment.'}, {'measure': 'Percentage of Participants With Post-treatment Relapse', 'timeFrame': 'From the end of treatment through 12 weeks after the last dose of study drug', 'description': 'Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug, excluding reinfection, among participants who completed treatment with HCV RNA levels \\< LLOQ at the end of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Hepatitis C Infection'], 'conditions': ['Hepatitis C Virus (HCV)']}, 'referencesModule': {'references': [{'pmid': '30980576', 'type': 'RESULT', 'citation': 'Poordad F, Sedghi S, Pockros PJ, Ravendhran N, Reindollar R, Lucey MR, Epstein M, Bank L, Bernstein D, Trinh R, Krishnan P, Polepally AR, Unnebrink K, Martinez M, Nelson DR. Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis. J Viral Hepat. 2019 Aug;26(8):1027-1030. doi: 10.1111/jvh.13109. Epub 2019 May 6.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic hepatitis C virus (HCV) infection\n* Non-cirrhotic subjects\n* Screening laboratory results showing HCV Genotype 1a (HCV GT1a) infection\n* HCV treatment-naïve or if treated previously, only with interferon (IFN) or pegylated interferon (pegINF) with or without ribavirin (RBV)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)\n* HCV genotype of any subtype other than GT1a or unable to subtype\n* Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN or RBV. Subjects with previous participation in trials of investigational direct-acting antiviral agents (DAAs) may be enrolled if they can produce documentation that they received only placebo.\n* Current enrollment in another interventional clinical study or receipt of any investigational product within 6 weeks prior to study drug administration.'}, 'identificationModule': {'nctId': 'NCT02609659', 'acronym': 'GEODE II', 'briefTitle': 'Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)', 'orgStudyIdInfo': {'id': 'M15-582'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3-DAA + RBV 600 mg', 'description': '3-DAA (ombitasvir/paritaprevir/ritonavir \\[25 mg/150 mg/100 mg once daily\\] and dasabuvir \\[250 mg twice daily\\]) plus RBV (ribavirin \\[600 mg once daily\\]) for 12 weeks.', 'interventionNames': ['Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir', 'Drug: ribavirin']}], 'interventions': [{'name': 'ombitasvir/paritaprevir/ritonavir and dasabuvir', 'type': 'DRUG', 'otherNames': ['Viekira Pak', 'paritaprevir also known as ABT-450', 'ombitasvir also known as ABT-267', 'dasabuvir also known as ABT-333'], 'description': 'Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet', 'armGroupLabels': ['3-DAA + RBV 600 mg']}, {'name': 'ribavirin', 'type': 'DRUG', 'description': 'Tablet', 'armGroupLabels': ['3-DAA + RBV 600 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AbbVie Inc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}