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.

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Copegus	1200-1600mg/day po
DRUG	Copegus	1000-1200mg/day po
DRUG	peginterferon alfa-2a [Pegasys]	360 micrograms sc weekly
DRUG	peginterferon alfa-2a [Pegasys]	180 micrograms sc twice weekly

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2006-12-18
• Last updated: 2016-04-05

Locations

22 sites across 1 country: France