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:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00412334

First received: December 15, 2006

Last updated: January 18, 2011

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2006

Last Updated Date

January 18, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sustained viral response [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Sustained viral response at week 72.

Change History

Complete list of historical versions of study NCT00412334 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: percentage of patients with >=2 log drop in HCV-RNA at weeks 4, 12 & 24; percentage of patients with undetectable HCV-RNA at end of treatment; relapse rate. Safety: AEs, lab parameters. QoL: HQLW, fatigue syndrome scale.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Interventions:
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: Copegus
Experimental: 2
Interventions:
- Drug: Copegus
- Drug: peginterferon alfa-2a [Pegasys]
Experimental: 3
Interventions:
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: Copegus
Experimental: 4
Interventions:
- Drug: peginterferon alfa-2a [Pegasys]
- Drug: Copegus

Publications *

Chevaliez S, Hézode 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-? and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). Gastroenterology. 2011 Jul;141(1):119-27. Epub 2011 Mar 24.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

104

Completion Date

September 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00412334

Other Study ID Numbers ^ICMJE

ML20399

Has Data Monitoring Committee

Not Provided

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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