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

Study results available
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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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00922779 on ClinicalTrials.gov