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48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection

NCT00114361 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2010-06-22

No results posted yet for this study

Summary

The purpose of this study is to investigate whether in patients with chronic HBeAg-negative hepatitis B, PEG-IFN-ribavirin combination therapy for 1 year leads to enhanced response (HBV DNA \<10E4 copies/ml and normal ALT 24 weeks after treatment discontinuation) in comparison with pegylated interferon (PEG-IFN) monotherapy.

Conditions

Interventions

DRUG

Ribavirin

1200 mg a day, 48 weeks

DRUG

Peginterferon alpha 2a

180 µg per week, 48 weeks

Sponsors & Collaborators

  • Foundation for Liver Research

    lead OTHER

Principal Investigators

  • Harry LA Janssen, MD PhD · Foundation of Liver Research

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2008-05-31
Completion
2010-04-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT00114361 on ClinicalTrials.gov