A single-arm, open-label, multi-centre pilot study evaluating the efficacy and safety of Ro 25-8310 combination therapy with Ro 20-9963 in pateints with chronic hepatitis C attending a methdone clinic
- Conditions
- Chronic hepatitis CInflammatory and Immune System - Liver
- Registration Number
- ACTRN12605000682640
- Lead Sponsor
- Melbourne Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Serological evidence of chronic hepatitis C infection by an anti-HCV antibody test for > 6 months; Detectable serum HCV-RNA; elevated serum ALT activity documented on at least two occasions at least one month apart withinthe last 6 months; liver biopsy findings consistant with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis; compensated liver disease; have had an episode of injecting drug use with 6 months of screening; on a recognized pharmacotherapy detoxification program such as Methadone, Buprenorhine, or Naltrexone.
Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab; History of other medical condition associated with chronic liver disease other than HCV.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of R0 25-8310 combination therapy on the clearance of HCV viraemia (sustained virological response) in recent injecting drug users with chronic hepatitis C (CHC) virus infection treated with pharmacotherapy.[24 weeks after treatment end.]
- Secondary Outcome Measures
Name Time Method To evaluate the proportion of patients who comply with the treatment regimen as defined as completion of at least 80% of treatment visits.[];To evaluate the psychological impact of therapy.[];To evaluate the impact of therpy on quality of life.[];To evaluate the effect of therapy on injecting behaviour.[];To evaluate the impact of therapy on pharmacotherapy.[]