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
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis C, Chronic
Intervention: Copegus (Drug); Copegus (Drug); peginterferon alfa-2a [Pegasys] (Drug); peginterferon alfa-2a [Pegasys] (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Angers 49033, France
Bobigny 93009, France
Chateauroux 36019, France
Creteil 94000, France
Creteil 94010, France
Grenoble 38043, France
Hyeres 83407, France
Lille 59037, France
Limoges 87042, France
Marseille 13285, France
Marseille 13385, France
Metz 57038, France
Montpellier 34295, France
Nice 06202, France
Paris 75651, France
Paris 75679, France
Pessac 33604, France
Poitiers 86021, France
Strasbourg 67091, France
Toulouse 31059, France
Vandoeuvre-les-nancy 54511, France
Villejuif 94804, France
Additional Information
Starting date: January 2007
Last updated: August 17, 2015
|