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

NCT ID: NCT00412334

Last Updated: 2016-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-09-30

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.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Copegus

Intervention Type: DRUG

1000-1200mg/day po

peginterferon alfa-2a [Pegasys]

Intervention Type: DRUG

360 micrograms sc weekly

2

Group Type: EXPERIMENTAL

Copegus

Intervention Type: DRUG

1000-1200mg/day po

peginterferon alfa-2a [Pegasys]

Intervention Type: DRUG

180 micrograms sc twice weekly

3

Group Type: EXPERIMENTAL

Copegus

Intervention Type: DRUG

1200-1600mg/day po

peginterferon alfa-2a [Pegasys]

Intervention Type: DRUG

360 micrograms sc weekly

4

Group Type: EXPERIMENTAL

Copegus

Intervention Type: DRUG

1200-1600mg/day po

peginterferon alfa-2a [Pegasys]

Intervention Type: DRUG

180 micrograms sc twice weekly

Interventions

Copegus

1200-1600mg/day po

Intervention Type: DRUG

Copegus

1000-1200mg/day po

Intervention Type: DRUG

peginterferon alfa-2a [Pegasys]

360 micrograms sc weekly

Intervention Type: DRUG

peginterferon alfa-2a [Pegasys]

180 micrograms sc twice weekly

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Angers, , France

Bobigny, , France

Châteauroux, , France

Créteil, , France

Créteil, , France

Grenoble, , France

Hyères, , France

Lille, , France

Limoges, , France

Marseille, , France

Marseille, , France

Metz, , France

Montpellier, , France

Nice, , France

Paris, , France

Paris, , France

Pessac, , France

Poitiers, , France

Strasbourg, , France

Toulouse, , France

Vandœuvre-lès-Nancy, , France

Villejuif, , France

Countries

France

References

Chevaliez S, Hezode C, Soulier A, Costes B, Bouvier-Alias M, Rouanet S, Foucher J, Bronowicki JP, Tran A, Rosa I, Mathurin P, Alric L, Leroy V, Couzigou P, Mallat A, Charaf-Eddine M, Babany G, Pawlotsky JM. High-dose pegylated interferon-alpha and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). Gastroenterology. 2011 Jul;141(1):119-27. doi: 10.1053/j.gastro.2011.03.039. Epub 2011 Mar 24.

Reference Type: DERIVED

PMID: 21439960 (View on PubMed)

Other Identifiers

ML20399

Identifier Type: -

Identifier Source: org_study_id