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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.

NCT01519921 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2016-04-21

Study results available
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Summary

This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

peginterferon alfa-2a [Pegasys]

Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • South Korea

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 NCT01519921 on ClinicalTrials.gov