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A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-1 Patients

NCT00629967 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2008-03-06

No results posted yet for this study

Summary

The purposes of this study are:

1. To evaluate whether treatment with peginterferon and ribavirin for 24 weeks is sufficient to achieve a sustained virological response (SVR) rate comparable to that observed with the standard treatment duration of 48 weeks, in hepatitis C virus genotype 1 (HCV-1) patients achieving a rapid virologic response (RVR; \<50 IU/mL HCV RNA at week 4) at 4 weeks.
2. To investigate the role of on-treatment virological responses among patients with 24 or 48 weeks treatment.

Conditions

  • Chronic Hepatitis C
  • Genotype

Interventions

DRUG

pegylated interferon alpha 2a and ribavirin

pegylated interferon alpha 2a 180 mcg/week and ribavirin 1000-1200 mg/day for 48 weeks

DRUG

Pegylated interferon alfa-2a and ribavirin

Pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks

Sponsors & Collaborators

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    lead OTHER

Principal Investigators

  • Ming-Lung Yu, MD, PhD · Kaohsiung Medical University

  • Chia-Yen Dai, MD, Ms · Kaohsiung Municipal Hsiao-Kang Hospital

  • Chang-Fu Chiu, MD · Paochien Hospital

  • Jee-Fu Huang, MD · Foo Yin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • Taiwan

Study Locations

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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 NCT00629967 on ClinicalTrials.gov