Clinical trial NCT00412334: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-12-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Sustained viral response
timeFrame: Week 72
Secondary outcomes:
measure: Percentage of patients with >=2log drop of HCV-RNA
timeFrame: Week 4, 12, 24.
measure: Percentage of patients with non-detectable HCV-RNA
timeFrame: Week 48
measure: Relapse rate
timeFrame: Throughout study.
Other outcomes:
Locations:
city: Angers
country: France
city: Bobigny
country: France
city: Chateauroux
country: France
city: Creteil
country: France
city: Creteil
country: France
city: Grenoble
country: France
city: Hyeres
country: France
city: Lille
country: France
city: Limoges
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Metz
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Pessac
country: France
city: Poitiers
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Vandoeuvre-les-nancy
country: France
city: Villejuif
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.