At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Chronic hepatitis C infection, genotype 1, 2, or 3
- ✓Treatment-naive for HCV
- ✓Enrolled in methadone maintenance program with documented attendance ≥3 months
- ✕Previous treatment for chronic hepatitis C
- ✕HIV co-infection
- ✕Current use of IV or other illicit drugs
- ✕Decompensated cirrhosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multi-Center, Randomized, Safety, Feasibility and Tolerability Pilot Study of Pegasys® (Peginterferon Alfa-2a) Plus Copegus® (Ribavirin) in Previous Intravenous Drug Users Who Are Currently Enrolled in a Methadone Maintenance Treatment Program.
In Brief
A Phase 4 clinical trial evaluating peginterferon alfa-2a [Pegasys] and ribavirin for Hepatitis C, Chronic. Completed, enrolled 48 participants across 7 sites.
Detailed Summary
This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.
Study Details
Timeline
Interventions
180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1)
1000/1200mg (\< or \>= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)