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100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)

NCT01378104 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2013-03-08

Study results available
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Summary

1. Randomized controlled multicenter study
2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
3. IL28B polymorphism in Koreans with CHC

Conditions

  • Sustained Virologic Response
  • IL28B Polymorphism

Interventions

DRUG

peginterferon alfa 2a (pegasys)

dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable

DRUG

peginterferon alfa-2a (pegasys)

These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.

Sponsors & Collaborators

  • Ulsan University Hospital

    collaborator OTHER

  • National Health Insurance Service Ilsan Hospital

    collaborator OTHER

  • Inje University

    collaborator OTHER

  • Soonchunhyang University Hospital

    collaborator OTHER

  • Yonsei University

    collaborator OTHER

  • Chungnam National University

    collaborator OTHER

  • Keimyung University

    collaborator OTHER

  • Kyungpook National University Hospital

    collaborator OTHER

  • Konyang University Hospital

    collaborator OTHER

  • Inha University Hospital

    collaborator OTHER

  • Hallym University Medical Center

    collaborator OTHER

  • The Catholic University of Korea

    lead OTHER

Principal Investigators

  • Jung Hyun Kwon, MD, Assistant professor · The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-09-30
Completion
2012-09-30

Countries

  • South Korea

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 NCT01378104 on ClinicalTrials.gov