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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


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-RNA

Percentage of patients with non-detectable HCV-RNA

Relapse rate


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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