drugset / Trial / NCT01258101

A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3

NCT01258101 ↗

Phase 4 Completed 395 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

Timeline

Start
2003-05
Primary completion
2008-07
Completion
2008-07

Outcome

Met primary endpoint

paper The SVR rate was statistically different in the two study groups with 51.6% in group C and 28.4% in group D (p = 0.038). PMID 21714878 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Subject Ribavirin Small molecule 400 mg Oral
Subject Ribavirin Small molecule 800 mg Oral