Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Non-Responder Patients With Chronic Hepatitis C (CHC)
Status: Completed
Protocol number: ML16788
Sponsor: Roche SAS
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of PEGASYS compared with daily vitamin E on fibrosis progression in patients with chronic hepatitis viral infection nonresponsive to pegylated interferon plus ribavirin
Brief summary: This study will evaluate the efficacy and safety of PEGASYS compared with that of daily vitamin E in patients with CHC who are non-responders to CHC treatments. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Target sample size is 200.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Efficacy: Improvement of 1 point on fibrosis score or stabilization on hepatic biopsy at Week 96 (Metavir) or 2 points (Ishak score)
Key secondary outcomes: 1. Efficacy: Virologic and biochemical response, fibrosis markers dosage
Safety: Adverse events, hemoglobin, other laboratory tests
Inclusion criteria:
- adult patients 18-74 years of age;
- CHC infection;
- not responsive to previous therapy with pegylated interferon + ribavirin;
- chronic liver disease consistent with CHC infection;
- compensated liver disease.
Exclusion criteria:
- women who are pregnant or breastfeeding;
- systemic anti-viral, anti-neoplastic, or immunomodulatory agent <=6 months before study;
- conditions associated with chronic liver disease;
- human immunodeficiency virus (HIV) infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: 74 Years
Accepts healthy volunteers: No
Trial registration date: 08/25/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
France
- Amiens
- Annecy
- Argenteuil
- Caen
- Chambray-Lès-Tours
- Clichy
- Corbeil-Essonnes
- Creteil
- Grenoble
- Hyeres
- Lomme
- Marseille
- Metz
- Nanterre
- Nice
- Paris
- Poitiers
- Rouen
- Saint Laurent Du Var
- St Dizier
- Strasbourg
- Toulouse
- Vandoeuvre-Les-Nancy
