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Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9

NCT00575224 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2009-11-25

No results posted yet for this study

Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of the drugs Pegasys and Copegus when used for hepatitis C genotypes 6, 7, 8, and 9. Patients are randomly assigned (by chance) to either Treatment Group A (Pegasys and Copegus for 24 weeks) or Treatment Group B (Pegasys and Copegus for 48 weeks).

Conditions

  • Chronic Hepatitis C
  • Asian Americans
  • Novel Genotypes
  • Treatment

Interventions

DRUG

Pegylated interferon and ribavirin

180 ug of peg-IFN per week and 1000-1200 mg of ribavirin per day (weight-dependent). Treatment duration is determined by treatment arm.

Sponsors & Collaborators

Principal Investigators

  • Mindie H Nguyen, M.D., M.A.S. · Stanford University Medical Center and Pacific Health Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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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 NCT00575224 on ClinicalTrials.gov