ClinicalTrials.Veeva

Menu

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

Roche logo

Roche

Status and phase

Completed
Phase 4

Conditions

Hepatitis C, Chronic

Treatments

Drug: Copegus
Drug: peginterferon alfa-2a [Pegasys]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00412334
ML20399

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 4 patient groups

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

Trial contacts and locations

22

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems