SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic
Intervention: peginterferon alfa-2a (40KD) [PEGASYS] (Drug); Copegus (Drug); peginterferon alfa-2a (40KD) [PEGASYS] (Drug); Copegus (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000
Overall contact:
Please reference Study ID Number: RLI_ML20399, Phone: 973-235-5000
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.
Clinical Details
Official 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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sustained viral response
Secondary outcome: Percentage of patients with >=2log drop of HCV-RNAPercentage of patients with non-detectable HCV-RNA Relapse rate
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Please reference Study ID Number: RLI_ML20399, Phone: 973-235-5000
CRETEIL 94010, France; Recruiting
VANDOEUVRE-LES-NANCY 54511, France; Recruiting
GRENOBLE 38043, France; Recruiting
NICE 06202, France; Recruiting
PARIS 75743, France; Recruiting
MARSEILLE 13385, France; Recruiting
STRASBOURG 67091, France; Recruiting
ANGERS 49033, France; Recruiting
LILLE 59037, France; Recruiting
VILLEJUIF 94804, France; Recruiting
METZ 57038, France; Recruiting
TOULOUSE 31059, France; Recruiting
MARSEILLE 13285, France; Recruiting
BOBIGNY 93009, France; Recruiting
MONTPELLIER 34295, France; Recruiting
LIMOGES 87042, France; Recruiting
CHATEAUROUX 36019, France; Recruiting
CRETEIL 94000, France; Recruiting
PARIS 75651, France; Recruiting
POITIERS 86021, France; Recruiting
PESSAC 33600, France; Recruiting
HYERES 83400, France; Recruiting
Additional Information
Starting date: January 2007
Ending date: February 2010
Last updated: July 16, 2008
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