SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00412334

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 (40KD) [PEGASYS] Drug: Copegus	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	120
Study Start Date:	January 2007
Estimated Study Completion Date:	February 2010

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 360 micrograms sc weekly Drug: Copegus 1000-1200mg/day po
2: Experimental	Drug: Copegus 1000-1200mg/day po Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc twice weekly
3: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 360 micrograms sc weekly Drug: Copegus 1200-1600mg/day po
4: Experimental	Drug: peginterferon alfa-2a (40KD) [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

CRETEIL, France, 94010

VANDOEUVRE-LES-NANCY, France, 54511

GRENOBLE, France, 38043

NICE, France, 06202

PARIS, France, 75679

MARSEILLE, France, 13385

STRASBOURG, France, 67091

ANGERS, France, 49033

LILLE, France, 59037

VILLEJUIF, France, 94804

METZ, France, 57038

HYERES, France, 83400

MARSEILLE, France, 13285

BOBIGNY, France, 93009

MONTPELLIER, France, 34295

LIMOGES, France, 87042

CHATEAUROUX, France, 36019

CRETEIL, France, 94000

PARIS, France, 75651

POITIERS, France, 86021

PESSAC, France, 33600

TOULOUSE, France, 31059

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20399
Study First Received:	December 15, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00412334
Health Authority:	France: AFSSAPS (Agence francaise de securite sanitaire des produits de sante)

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009