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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).

NCT00077649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2016-04-18

Study results available
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Summary

The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

ribavirin [Copegus]

600mg po bid for 48 weeks

DRUG

ribavirin [Copegus]

800mg po bid for 48 weeks

DRUG

peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

180 micrograms sc weekly for 48 weeks

DRUG

peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

270 micrograms sc weekly for 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

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 NCT00077649 on ClinicalTrials.gov