Trial information
SYREN Study: A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.
Status: Recruiting
Protocol number: ML20399
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Antiviral effect of 4 regimens of PEGASYS plus Copegus in patients with genotype 1 chronic hepatitis C non-responder to previous Peginterferon alfa-2a plus ribavirin therapy
Brief summary: This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 120.
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: 1. Sustained viral response Time frame: Week 72
Key secondary outcomes: 1. Percentage of patients with >=2log drop of HCV-RNA Time frame: Week 4, 12, 24.
2. Percentage of patients with non-detectable HCV-RNA Time frame: Week 48
3. Relapse rate Time frame: Throughout study.
Inclusion criteria:
- adult patients >=18 years of age, with CHC genotype 1;
- patients who have failed to respond to previous treatment with PEGASYS plus ribavirin for >=12 weeks;
- patients who have discontinued PEGASYS/ribavirin >=4 weeks prior to enrollment;
- compensated liver disease.
Exclusion criteria:
- other forms of liver disease;
- infection with HIV, HAV, HBV;
- hepatocellular cancer.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: January, 2007
Trial registration date: 12/18/2006
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Angers
- Bobigny
- Chateauroux
- Creteil
- Grenoble
- Hyeres
- Lille
- Limoges
- Marseille
- Metz
- Montpellier
- Nice
- Paris
- Pessac
- Poitiers
- Strasbourg
- Toulouse
- Vandoeuvre-Les-Nancy
- Villejuif
