Conditions: Hepatitis C, Chronic
Keywords: Prevention of Relapse HCV genotype 1b Recurrence
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 169
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether lozenges of interferon-alpha that are dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who had a complete virologic response after receiving a combination of injected interferon-alpha and oral ribavirin.

Detailed description:

Arms:
arm 1: 500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day arm 2: 500 IU interferon-alpha lozenge taken 3 times per day arm 3: placebo lozenges taken 3 times per day

Interventions: intervention 1: interferon-alpha lozenges intervention 2: placebo lozenges
Intervention descriptions: intervention 1: 500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks intervention 2: 200 mg matching placebo lozenges

Protocol document: