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Entecavir and Pegasys Sequential Therapy Versus Pegasys for HBeAg Positive Chronic Hepatitis B

NCT00921180 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2012-12-20

No results posted yet for this study

Summary

Currently, peginterferon alfa-2a or oral nucleos(t)ides are approved for the treatment with HBeAg positive CHB, with the overall HBeAg seroconversion far from satisfactory. Therefore, efforts on the various combinations with the currently available drugs are needed to improve the overall response rates. The simultaneous combination therapy with oral nucleoside and peginterferon alfa-2a from large-scaled randomized trials did not show a superior response rate over peginterferon alfa-2a monotherapy. Recently, sequential monotherapy with lamivudine for the first 4 weeks, followed by weekly peginterferon alfa-2a has shown favorable HBeAg seroconversion rate over peginterferon alfa-2a monotherapy, based on the assumption that early viral suppression by lamivudine can restore the immune function to facilitate the later immunomodulatory response by peginterferon alfa-2a. With the recent introduction of entecavir, the more potent oral nucleoside with few drug resistance, sequential monotherapy with entecavir can potently suppress HBV DNA with 4 weeks of treatment, which may facilitate the response of peginterferon alfa-2a to achieve HBeAg seroconversion. Therefore, we aimed to conduct a placebo controlled randomized control trial to evaluate of adding entecavir early in the course of therapy can improve the treatment response.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Entecavir and peginterferon alfa-2a

Entecavir (Baraclude) 0.5 mg/day po at week 1-4 Peginterferon alfa-2a (Pegasys) 180 ug/week sc at week 5-52

DRUG

Placebo and peginterferon

Placebo 0.5 mg/day po at week 1-4 Peginterferon alfa-2a (Pegasys) 180 ug/week sc at week 5-52

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chen-Hua Liu, MD · National Taiwan University Hospital

  • Jia-Horng Kao, MD, PhD · National Taiwan University Hospital

  • Shih-Jer Hsu, MD · National Taiwan University Hosptial, Yun-Lin Branch

  • Chih-Lin Lin, MD · Ren-Ai Branch, Taipei City Hospital

  • Cheng-Chao Liang, MD · Far Eastern Memorial Hospital

  • Ching-Sheng Hsu, MD · Buddhist Tzu Chi General Hospital

  • Sheng-Shun Yang, MD, PhD · Taichung Veterans General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2013-12-31
Completion
2013-12-31

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 NCT00921180 on ClinicalTrials.gov