A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
NCT00922779 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6661
Last updated 2016-01-20
Summary
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.
Conditions
- Hepatitis C, Chronic
Interventions
- DRUG
-
peginterferon alfa-2a [Pegasys]
180micrograms sc weekly for 12-48 weeks
- DRUG
-
ribavirin
800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-06-30
- Primary Completion
- 2012-06-30
- Completion
- 2012-06-30
Countries
- Russia
Study Locations
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