Chronic Hepatitis C Infection Clinical Trial
— Turquoise-IVOfficial title:
An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)
A study to evaluate chronic hepatitis C infection in cirrhotic adults with genotype 1b infection.
Status | Completed |
Enrollment | 36 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening) - evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening - Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control Exclusion Criteria: - Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody - evidence of current or past Child-Pugh B or C classification - confirmed presence of hepatocellular carcinoma - abnormal laboratory tests - self-reports current drinking more than 2 drinks per day - previous treatment with a direct acting antiviral agent (DAA) containing regimen |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belarus | Site Reference ID/Investigator# 129376 | Minsk | |
Russian Federation | Site Reference ID/Investigator# 127302 | Moscow | |
Russian Federation | Site Reference ID/Investigator# 127305 | Moscow | |
Russian Federation | Site Reference ID/Investigator# 127306 | Moscow | |
Russian Federation | Site Reference ID/Investigator# 128341 | Moscow | |
Russian Federation | Site Reference ID/Investigator# 128342 | Moscow | |
Russian Federation | Site Reference ID/Investigator# 127303 | Stavropol |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
Belarus, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of subjects with sustained virologic response 12 weeks post-treatment | Hepatitis C Virus ribonucleic acid less than the lower limit of quantification | 12 weeks after the last dose of study drug | No |
Secondary | Percentage of subjects with virologic failure during treatment | Hepatitis C Virus ribonucleic acid greater than the lower limit of quantification | Up to Week 12 | No |
Secondary | Percentage of subjects with virologic relapse after treatment | Hepatitis C virus ribonucleic acid greater than the lower limit of quantification | Up to post-treatment Week 24 | No |
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