NCT00483938

The Individualized Management With Pegylated-interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Offering Viral Eradication: A Study of Pegylated-interferon Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C (CHC) Non-genotype 2/3 (IMPROVE)

The Individualized Management With Pegasys and Ribavirin Offering Viral Eradication (IMPROVE) Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (\>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram \[mg\]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (\<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Pegylated-interferon Alfa-2a	Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for the specified duration.
DRUG	Ribavirin	Participants will receive ribavirin 1000 to 1400 mg orally daily for the specified duration.

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2007-06-08
• Last updated: 2017-01-23
• Results posted: 2017-01-23

Locations

23 sites across 2 countries: United States, Canada