Status:
COMPLETED
Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
Lead Sponsor:
AbbVie
Conditions:
HCV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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.
Eligibility Criteria
Inclusion
- Main Selection Criteria for Healthy Volunteers:
- Subject has provided written consent.
- Subject is in general good health.
- If female, subject is postmenopausal.
- If female, subject is not pregnant and is not breast-feeding.
- Main Selection Criteria for HCV+ Subjects:
- Subject is HAV-IgM, HBsAg or HIV Ab negative.
- Subject is HCV genotype 1 with HCV RNA of \> 50,000 IU/mL.
- Subject is excluded if they have previously received antiviral therapy for HCV infection
- Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment
- 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.
Exclusion
- See above for main selection criteria
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00696904
Start Date
June 1 2008
Last Update
November 21 2017
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