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)

Completed · Phase 3

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00483938

Run by

Hoffmann-La Roche

People needed

236

Starts

2007-06-01

Expected to finish

2010-05-01

Last updated by the study team

2017-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• evidence of CHC;
• evidence of hepatitis C non-genotype 2 or 3;
• compensated liver disease.

You may not qualify if…

• infection with HCV genotype 2 or 3;
• history of having received systemic antiviral therapy with activity against CHC <=3 months prior to start of study;
• hepatitis A, hepatitis B or human immunodeficiency virus (HIV) infection;
• history or evidence of a medical condition associated with chronic liver disease other than CHC.

Where it is running

• Study site — Milwaukee, Wisconsin, United States
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Abbotsford British Columbia, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Vernon, British Columbia, Canada
• Study site — Victoria, British Columbia, Canada
• Study site — Halifax, Nova Scotia, Canada
• Study site — East York, Ontario, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — Kingston, Ontario, Canada
• Study site — London, Ontario, Canada
• Study site — Mississauga, Ontario, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Woodbridge, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Saskatoon, Saskatchewan, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.