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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000682640
Enrollment
50
Registered
2005-10-21
Start date
2001-02-21
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Combination therapy

Sponsors

Melbourne Health
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

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 criteria

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026