At a glance
ClinicalIndex Comparison Record- ✓Adult age ≥18 years
- ✓Body weight >85 kg (187 lbs)
- ✓Chronic hepatitis C genotype 1 infection
- ✓Liver biopsy within 24 months with findings consistent with CHC
- ✕Pregnancy or breastfeeding
- ✕Male partners of pregnant women
- ✕Decompensated liver disease
- ✕Other forms of liver disease including hepatocellular carcinoma
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Multicenter, Double-blind, Phase IV Pilot Study Evaluating the Effect of PEGASYS Doses of 180 ug or 270 ug in Combination With Copegus Doses of 1200 mg or 1600 mg on Viral Kinetics, Virological Response, Pharmacokinetics, and Safety in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Body Weight Greater Than 85 kg
In Brief
A Phase 4 clinical trial evaluating ribavirin [Copegus] and peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] for Hepatitis C, Chronic. Completed, enrolled 188 participants across 25 sites in 2 countries.
Detailed Summary
The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Study Details
Timeline
Interventions
600mg po bid for 48 weeks
800mg po bid for 48 weeks
180 micrograms sc weekly for 48 weeks
270 micrograms sc weekly for 48 weeks