SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.
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
1 other identifier
interventional
104
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2007
Longer than P75 for phase_4
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2006
CompletedFirst Posted
Study publicly available on registry
December 18, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedApril 5, 2016
April 1, 2016
3.7 years
December 15, 2006
April 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained viral response
Week 72
Secondary Outcomes (3)
Percentage of patients with >=2log drop of HCV-RNA
Week 4, 12, 24.
Percentage of patients with non-detectable HCV-RNA
Week 48
Relapse rate
Throughout study.
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- other forms of liver disease;
- infection with HIV, HAV, HBV;
- hepatocellular cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Angers, 49033, France
Unknown Facility
Bobigny, 93009, France
Unknown Facility
Châteauroux, 36019, France
Unknown Facility
Créteil, 94000, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Grenoble, 38043, France
Unknown Facility
Hyères, 83407, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Limoges, 87042, France
Unknown Facility
Marseille, 13285, France
Unknown Facility
Marseille, 13385, France
Unknown Facility
Metz, 57038, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Paris, 75679, France
Unknown Facility
Pessac, 33604, France
Unknown Facility
Poitiers, 86021, France
Unknown Facility
Strasbourg, 67091, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Vandœuvre-lès-Nancy, 54511, France
Unknown Facility
Villejuif, 94804, France
Related Publications (1)
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.
PMID: 21439960DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2006
First Posted
December 18, 2006
Study Start
January 1, 2007
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
April 5, 2016
Record last verified: 2016-04