SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.
Status and phase
Conditions
Treatments
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
Sex
Ages
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
Allocation
Interventional model
Masking
104 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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