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A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

NCT01086085 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2016-11-02

No results posted yet for this study

Summary

This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a \[PEGASYS\] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is \>2 years.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Adefovir

Adefovir 10 mg po once daily for 36 weeks

DRUG

peginterferon alfa-2a [PEGASYS]

Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks

DRUG

peginterferon alfa-2a [PEGASYS]

Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks

DRUG

peginterferon alfa-2a [PEGASYS]

Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks

Sponsors & Collaborators

  • Major Science and Technology Special Project of China Eleventh Five-year

    collaborator OTHER

  • Hoffmann-La Roche

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

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 NCT01086085 on ClinicalTrials.gov