Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT00696904
Status:
COMPLETED
Last Update Posted:
2017-11-21
First Post:
2008-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C588260', 'term': 'dasabuvir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2008-06-11', 'studyFirstSubmitQcDate': '2008-06-12', 'lastUpdatePostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.', 'timeFrame': 'approximately 1 week or less'}, {'measure': 'Analysis of safety measures, including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.', 'timeFrame': 'approximately 1 week'}], 'secondaryOutcomes': [{'measure': 'Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting.', 'timeFrame': 'approximately 1 week'}]}, 'conditionsModule': {'conditions': ['HCV Infection']}, 'referencesModule': {'references': [{'pmid': '26597291', 'type': 'RESULT', 'citation': 'Mensing S, Polepally AR, Konig D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies. AAPS J. 2016 Jan;18(1):270-80. doi: 10.1208/s12248-015-9846-1. Epub 2015 Nov 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333 in healthy volunteers and the antiviral activity in HCV infected subjects.', 'detailedDescription': 'Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and pharmacokinetics of ABT-333.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Main Selection Criteria for Healthy Volunteers:\n\n * Subject has provided written consent.\n * Subject is in general good health.\n * If female, subject is postmenopausal.\n * If female, subject is not pregnant and is not breast-feeding.\n* Main Selection Criteria for HCV+ Subjects:\n\n * Subject is HAV-IgM, HBsAg or HIV Ab negative.\n * Subject is HCV genotype 1 with HCV RNA of \\> 50,000 IU/mL.\n * Subject is excluded if they have previously received antiviral therapy for HCV infection\n * Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment\n * Subjects must have a prior liver biopsy with histology consistent with HCV induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.\n\nExclusion Criteria:\n\nSee above for main selection criteria'}, 'identificationModule': {'nctId': 'NCT00696904', 'briefTitle': 'Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'orgStudyIdInfo': {'id': 'M10-351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Healthy volunteers, receiving 10-1200 mg ABT-333 or placebo, single dose', 'interventionNames': ['Drug: ABT-333', 'Drug: Placebo']}, {'type': 'OTHER', 'label': '2', 'description': 'HCV+ treatment-naive subjects receiving 100-300 mg ABT-333 or placebo, multi-dose, QD or BID', 'interventionNames': ['Drug: ABT-333', 'Drug: Placebo']}, {'type': 'OTHER', 'label': '3', 'description': 'Healthy volunteers, receiving 100 mg ABT-333, multi-dose, food effect', 'interventionNames': ['Drug: ABT-333']}], 'interventions': [{'name': 'ABT-333', 'type': 'DRUG', 'description': 'Capsule, see arms for intervention description', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule, see arms for intervention description', 'armGroupLabels': ['1', '2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Daniel Cohen, MD, Study Medical Director', 'oldOrganization': 'Abbott'}}}}