Trial information
A Study of Combination Therapy With PEGASYS (Peginterferon alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response.
Status: Recruiting
Protocol number: MV21371
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effects of 24 vs 48 weeks of combination therapy with PEGASYS (peginterferon alfa-2a 40KD) plus COPEGUS (Ribavirin) on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3 who do not achieve a rapid viral response.
Brief summary: This study will evaluate the efficacy and safety of PEGASYS + Copegus combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3. Patients receiving PEGASYS (180 micrograms sc weekly) + Copegus (800-1200mg po daily) who do not achieve a rapid viral response at week 4 will enter the study between treatment week 6 and 8, and will receive study medication. Those who have an early virological response at week 12, and are still taking medication at week 24, will then be randomized to one of 2 study groups. Group 1 will stop treatment at this point and will have a 48 week post-treatment observation period, and Group 2 will stay on medication for a further 24 weeks, followed by a 24 week post-treatment observation period. The anticipated time on study treatment is 6-12 months, and the target sample size is 100-500 individuals. Target sample size is 400.
Study phase: III
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: 1. SVR Time frame: 24 weeks post-treatment (week 48 for Group 1, and week 72 for Group 2).
Key secondary outcomes: 1. Percentage of patients with non-detectable HCV-RNA Time frame: End of treatment (week 24 for Group 1 and week 48 for Group 2)
2. Percentage of patients with >=2 log10 drop in HCV-RNA Time frame: Treatment week 12
3. AEs, laboratory parameters. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- serological evidence of chronic hepatitis C (CHC);
- CHC genotype 2 or 3;
- receiving PEGASYS + Copegus according to local standard of care and no RVR;
- compensated liver disease.
Exclusion criteria:
- pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
- coinfection with hepatitis A or B, or HIV;
- history or other evidence of decompensated liver disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2008
Trial registration date: 02/15/2008
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Austria
Belgium
- Antwerpen
- Bruxelles
- Gent
- Kortrijk
- Liege
Brazil
- Brasilia
- Campinas
- Curitiba
- Porto Alegre
- Ribeirão Preto
- Rio De Janeiro
- Santo Andre
- Sao Luis
- Sao Paulo
- Sorocaba
- Vitoria
Germany
- Berlin
- Bonn
- Düsseldorf
- Frankfurt Am Main
- Freiburg
- Hamburg
- Heidelberg
- Kiel
- Köln
- Mainz
- München
- Tübingen
- Ulm
Mexico
- Guadalajara
- Mexicali
- Mexico City
- Monterrey
- Puebla
- Tijuana
New Zealand
- Auckland
- Christchurch
- Hamilton
Switzerland
- Lausanne
- Lugano
- St Gallen
- Zürich
United States
- Birmingham, AL
- La Jolla, CA
- Lancaster, CA
- Long Beach, CA
- Sacramento, CA
- San Diego , CA
- Aurora, CO
- Jacksonville, FL
- Orlando, FL
- Atlanta, GA
- Marietta, GA
- Honolulu, HI
- Baton Rouge, LA
- Opelousas, LA
- Boston, MA
- St Louis, MO
- Egg Harbour Township, NJ
- Albuquerque, NM
- New York, NY
- Syracuse, NY
- Asheville, NC
- Winston-Salem, NC
- Portland, OR
- Santurce, PR
- Kingsport, TN
- Fort Sam Houston, TX
- Charlottesville, VA
- Fairfax , VA
- Richmond, VA
