PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)

NCT01056172 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2012-04-20

No results posted yet for this study

Summary

This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Peginterferon alfa-2a and Ribavirin

1. PegIFN alfa-2a (PEgasys) 180 ug/week 2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day) 3. Treatment duration: 16 weeks

DRUG

Peginterferon alfa-2a and Ribavirin

1. PegIFN alfa-2a (PEgasys) 180 ug/week 2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day) 3. Treatment duration: 24 weeks

Sponsors & Collaborators

  • Severance Hospital

    collaborator OTHER
  • Pusan National University Hospital

    collaborator OTHER
  • Incheon St.Mary's Hospital

    collaborator OTHER
  • Soon Chun Hyang University

    collaborator OTHER
  • Inje University

    collaborator OTHER
  • Inje University Ilsan Paik Hospital

    collaborator OTHER
  • Inje University Haeundae Paik Hospital

    collaborator OTHER
  • Pusan National University Yangsan Hospital

    lead OTHER

Principal Investigators

  • Ki Tae Yoon, M.D · Pusan National University Yangsan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-06-30
Completion
2012-12-31

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 NCT01056172 on ClinicalTrials.gov