Conditions: Hepatitis C
Keywords: HCV interferon-naive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
The study is intended to determine whether CTS-1027 either alone or in combination with ribavirin is safe and effective in Hepatitis C patients who have not previously been treated with interferon.

Detailed description:
There are approximately 1 million Hepatitis C (HCV) patients in the US who have failed to respond to, or cannot tolerate, interferon or interferon plus ribavirin therapy. Significant adverse effects of interferon therapy include bone marrow depression (with reduced white blood cell and platelet counts) and major psychiatric disorders (especially depression). Ribavirin is associated with hemolytic anemia in a minority of patients who are treated with it. Patients with chronic HCV infection have a very low incidence of spontaneous viral clearance, have progressive disease, and have a continuing medical need for more efficacious and safer therapy. There is a significant unmet medical need for therapy in HCV patients who cannot (or will not) tolerate interferon-based treatment.

This trial will evaluate the effects of CTS-1027 with or without ribavirin in patients who are previously untreated with interferon including patients with major psychiatric disorders, uncontrolled autoimmune disease, and patients who simply decline treatment.

Arms:
arm 1: Study drug plus ribavirin arm 2: Study drug plus placebo for ribavirin

Interventions: intervention 1: ribavirin intervention 2: CTS-1027 intervention 3: Placebo for ribavirin
Intervention descriptions: intervention 1: 200 mg capsules, either 1000 or 1200 mg taken twice daily for up to 24 weeks intervention 2: 5 and 10 mg tablets, 15 mg taken twice daily, for up to 24 weeks intervention 3: Capsules identical to ribavirin in appearance containing inactive ingredients

Protocol document: