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)

Australia

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ACTRN12605000682640