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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.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: December 15, 2006
Last updated: April 2, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus
Drug: peginterferon alfa-2a [Pegasys]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained viral response [ Time Frame: Week 72 ]

Secondary Outcome Measures:
  • Percentage of patients with >=2log drop of HCV-RNA [ Time Frame: Week 4, 12, 24. ]
  • Percentage of patients with non-detectable HCV-RNA [ Time Frame: Week 48 ]
  • Relapse rate [ Time Frame: Throughout study. ]

Enrollment: 104
Study Start Date: January 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Copegus
1000-1200mg/day po
Drug: peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly
Experimental: 2 Drug: Copegus
1000-1200mg/day po
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc twice weekly
Experimental: 3 Drug: Copegus
1200-1600mg/day po
Drug: peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly
Experimental: 4 Drug: Copegus
1200-1600mg/day po
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc twice weekly


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00412334

Angers, France, 49033
Bobigny, France, 93009
Chateauroux, France, 36019
Creteil, France, 94000
Creteil, France, 94010
Grenoble, France, 38043
Hyeres, France, 83407
Lille, France, 59037
Limoges, France, 87042
Marseille, France, 13285
Marseille, France, 13385
Metz, France, 57038
Montpellier, France, 34295
Nice, France, 06202
Paris, France, 75651
Paris, France, 75679
Pessac, France, 33604
Poitiers, France, 86021
Strasbourg, France, 67091
Toulouse, France, 31059
Vandoeuvre-les-nancy, France, 54511
Villejuif, France, 94804
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00412334     History of Changes
Other Study ID Numbers: ML20399
Study First Received: December 15, 2006
Last Updated: April 2, 2016

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017