JPRN-jRCT2080221883
Unknown
Phase 2
A clinical study to evaluate the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in treatment experienced Japanese adults with chronic Hepatitis C Virus infection
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AbbVie GK
- Enrollment
- 96
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female between the age 18 and 75 years, inclusive.
- •\-Previously received Pegylated interferon alpha\-2a/Ribavirin.
- •\-Chronic hepatitis C virus infection.
- •\-Plasma hepatitis C virus ribonucleic acid level greater than 10,000 International Units/milliliter.
- •\-Voluntarily sign an informed consent.
Exclusion Criteria
- •\-Histry of severe, life\-threatening sensitivity to any drug.
- •\-Females who are pregnant or plan to become pregnant, or breastfeeding.
- •\-Recent histry of drug or alcohol abuse.
- •\-Positive test result for hepatitis B surface antigen or anti\-Human immunodeficiency virus antibodies.
- •\-Any current or past clinical evidence of cirrhosis.
- •\-Previous use of any investigational or commerciallyavailable anti\-Hepatitis C virus agent other than Pegylated interferon alpha\-2a and Ribavirin, including previous exposure to ABT\-450 or ABT\-267\.
Outcomes
Primary Outcomes
Not specified
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