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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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00412334
First received: December 15, 2006
Last updated: June 18, 2013
Last verified: June 2013
History of Changes
  Purpose

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: peginterferon alfa-2a [Pegasys]
Drug: Copegus
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained viral response [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with >=2log drop of HCV-RNA [ Time Frame: Week 4, 12, 24. ] [ Designated as safety issue: No ]
  • Percentage of patients with non-detectable HCV-RNA [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Relapse rate [ Time Frame: Throughout study. ] [ Designated as safety issue: No ]

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: peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly
Drug: Copegus
1000-1200mg/day po
Experimental: 2 Drug: Copegus
1000-1200mg/day po
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc twice weekly
Experimental: 3 Drug: peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly
Drug: Copegus
1200-1600mg/day po
Experimental: 4 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc twice weekly
Drug: Copegus
1200-1600mg/day po

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412334

Locations
France
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, 13385
Marseille, France, 13285
Metz, France, 57038
Montpellier, France, 34295
Nice, France, 06202
Paris, France, 75679
Paris, France, 75651
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00412334     History of Changes
Other Study ID Numbers: ML20399
Study First Received: December 15, 2006
Last Updated: June 18, 2013
Health Authority: France: AFSSAPS (Agence francaise de securite sanitaire des produits de sante)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013