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Clinical trialNCT00532701CompletedPhase 4Interventional

Peginterferon Alfa-2a and Ribavirin for Genotype 2 Chronic Hepatitis C: Duration and Ribavirin Dose Stratified by RVR

SponsorNational Taiwan University HospitalEnrollment880Chronic Hepatitis C
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Treatment with peginterferon plus daily low dose (800 mg) or weight-based ribavirin (800-1400 mg) for 24 to 48 weeks has achieved 70-93% sustained virologic response (SVR) rates in patients with genotype 2 or 3 chronic hepatitis C (CHC). Recently, a large randomized study has shown that patients with genotype 2 or 3 CHC have comparable SVR rates for those who received peginterferon for 24 or 48 weeks, and who received daily low dose (800 mg) or standard dose (1000-1200 mg) ribavirin. Therefore, the currently recommended treatment for these patients is 24 weeks of peginterferon plus low dose ribavirin. Because of the high response rates, several studies have shown that when these patients had rapid virologic response (RVR), defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, at week 4 of peginterferon plus weight-based ribavirin, 12-16 weeks of treatment could have 82-94% SVR rates. However, treatment with peginterferon plus low dose ribavirin for 24 weeks showed significantly higher SVR rates than that for 16 weeks (85% versus 79%) in these patients who achieved RVR. While studies showed concordant results in SVR rates for patients with genotype 3 CHC who received peginterferon plus low dose or weight-based ribavirin for 16 or 24 weeks, the SVR rates stratified by RVR showed great differences in patients with genotype 2 CHC who received such treatment. Currently, there are no studies on the direct comparison of low dose versus weight-based ribavirin, and of 16 to 24 weeks of treatment stratified by RVR for patients with genotype 2 CHC. The investigators aimed to conduct a randomized trial to determine the optimal ribavirin dose and treatment duration of peginterferon plus ribavirin for patients with genotype 2 CHC based on RVR studies.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Taiwan
  • National Taiwan University Hospital, Yun-Lin Branch

    Douliu, Taiwan

  • Kaohsiung Medical University

    Kaohsiung City, Taiwan

  • Kaohsiung Municipal Hsiao-Kang Hospital

    Kaohsiung City, Taiwan

  • Paochien Hospital

    Pingtung City, Taiwan

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Buddhist Xindian Tzu Chi General Hospital

    Taipei, Taiwan

  • Far Eastern Memorial Hospital

    Taipei, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Ren-Ai Branch, Taipei Municipal Hospital

    Taipei, Taiwan

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Peg-IFN + LD RBV for 16 weeksPeg-IFN + LD RBV for 24 weeksPeg-IFN + WB RBV for 16 weeksPeg-IFN + WB RBV for 24 weeksPeg-IFN + WB RBV for 48 weeks
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2007
Primary completion
31 Mar 2014
Completion
31 Mar 2014
Last update posted
4 Jun 2014
Registered enrollment
880
Registry id
NCT00532701

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.