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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.

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ClinicalTrials.gov Identifier: NCT00412334
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

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
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Hepatitis
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
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs