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Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.

NCT01220596 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2011-07-04

No results posted yet for this study

Summary

Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B.

* Increased HBeAg seroconversion rate
* Increased HBsAg loss rate
* To define the best treatment condition for chronic HBV hepatitis patients

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Entecavir and Pegylated interferon α-2a Sequential Treatment Group

Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks

DRUG

Pegylated interferon α-2a Monotreatment Group

Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Hanyang University

    lead OTHER

Principal Investigators

  • Joo Hyun Sohn, MD, Ph.D · Hanyang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

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 NCT01220596 on ClinicalTrials.gov