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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.

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Copegus

peginterferon alfa-2a [Pegasys]

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Sustained viral response

Secondary Outcome Measures

Percentage of patients with >=2log drop of HCV-RNA

Percentage of patients with non-detectable HCV-RNA

Relapse rate

Full Information

NCT ID

NCT00412334

First Posted

December 15, 2006

Last Updated

April 2, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00412334

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Copegus

Intervention Description

1200-1600mg/day po

Intervention Type

Drug

Intervention Name(s)

Copegus

Intervention Description

1000-1200mg/day po

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a [Pegasys]

Intervention Description

360 micrograms sc weekly

Intervention Type

Drug

Intervention Name(s)

peginterferon alfa-2a [Pegasys]

Intervention Description

180 micrograms sc twice weekly

Primary Outcome Measure Information:

Title

Sustained viral response

Time Frame

Week 72

Secondary Outcome Measure Information:

Title

Percentage of patients with >=2log drop of HCV-RNA

Time Frame

Week 4, 12, 24.

Title

Percentage of patients with non-detectable HCV-RNA

Time Frame

Week 48

Title

Relapse rate

Time Frame

Throughout study.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Angers

ZIP/Postal Code

49033

Country

France

City

Bobigny

ZIP/Postal Code

93009

Country

France

City

Chateauroux

ZIP/Postal Code

36019

Country

France

City

Creteil

ZIP/Postal Code

94000

Country

France

City

Creteil

ZIP/Postal Code

94010

Country

France

City

Grenoble

ZIP/Postal Code

38043

Country

France

City

Hyeres

ZIP/Postal Code

83407

Country

France

City

Lille

ZIP/Postal Code

59037

Country

France

City

Limoges

ZIP/Postal Code

87042

Country

France

City

Marseille

ZIP/Postal Code

13285

Country

France

City

Marseille

ZIP/Postal Code

13385

Country

France

City

Metz

ZIP/Postal Code

57038

Country

France

City

Montpellier

ZIP/Postal Code

34295

Country

France

City

Nice

ZIP/Postal Code

06202

Country

France

City

Paris

ZIP/Postal Code

75651

Country

France

City

Paris

ZIP/Postal Code

75679

Country

France

City

Pessac

ZIP/Postal Code

33604

Country

France

City

Poitiers

ZIP/Postal Code

86021

Country

France

City

Strasbourg

ZIP/Postal Code

67091

Country

France

City

Toulouse

ZIP/Postal Code

31059

Country

France

City

Vandoeuvre-les-nancy

ZIP/Postal Code

54511

Country

France

City

Villejuif

ZIP/Postal Code

94804

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

21439960

Citation

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.

Results Reference

derived

Learn more about this trial

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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