Trial information
IMPROVE Study(The Individualized Management with PEGASYS and Ribavirin Offering Viral Eradication): A Study of PEGASYS® (Peginterferon alfa-2a (40KD)) Plus Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Non-Genotype 2/3.
Status: Recruiting
Protocol number: ML21035
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study to evaluate the effect of 48 or 72 weeks of treatment with Pegasys plus Copegus combination therapy on sustained viral response in non-genotype 2/3 patients with chronic hepatitis C who show a response at week 12
Brief summary: This study will compare the efficacy and safety of 48 weeks and 72 weeks treatment with PEGASYS plus ribavirin in patients with non-genotype 2/3 chronic hepatitis C who, after 12 weeks of study treatment, have undetectable HCV-RNA or a >=2 log10 drop in HCV-RNA. Patients will be randomized to receive PEGASYS 180µg sc weekly plus ribavirin (1000-1400mg) po daily for either 48 or 72 weeks, followed by 24 weeks of treatment-free follow-up. Patients with detectable HCV-RNA and <2 log10 drop in HCV-RNA at week 12 will discontinue therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 500 individuals. Target sample size is 500.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: Sustained virologic response. Timeframe: 24 weeks post-treatment.
Key secondary outcomes: SVR. Timeframe: At intervals post-treatment. Viral kinetics. Timeframe: At intervals during study. AEs, laboratory parameters. Timeframe: Throughout study.
Inclusion criteria:
- adult patients, >=18 years of age;
- evidence of CHC;
- evidence of hepatitis C non-genotype 2 or 3;
- compensated liver disease.
Exclusion criteria:
- 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 HIV infection;
- history or evidence of a medical condition associated with chronic liver disease other than CHC.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/07/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Canada
- Calgary, AB
- Edmonton, AB
- Abbotsford, BC
- Vancouver, BC
- Vernon, BC
- Victoria, BC
- Halifax, NS
- Hamilton, ON
- Kingston, ON
- London, ON
- Mississauga, ON
- Ottawa, ON
- Toronto, ON
- Montreal, QC
- Saskatoon, SK
