A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00922779

ML16709

Details and patient eligibility

About

This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (< and >75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

Enrollment: 6,661 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• serological evidence of chronic hepatitis C;
• detectable serum HCV-RNA;
• liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion criteria

• history or other evidence of a medical condition associated with chronic liver disease other than HCV;
• co-infection with active hepatitis A or B;
• hepatocellular carcinoma;
• patients with severe cardiovascular disease whose condition may worsen due to acute anemia.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6,661 participants in 1 patient group

1

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: ribavirin