RecruitingACTRN12605000682640
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
Sponsor
Melbourne Health
Enrollment
50 participants
Start Date
Feb 21, 2001
Study Type
Interventional
Eligibility
Sex: Both males and females
Inclusion Criteria1
- 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.
Exclusion Criteria1
- 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.
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Interventions
Combination therapy
Combination therapy
Locations(1)
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ACTRN12605000682640