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PEG-IFN in HBV Patients With Incomplete Response to NA

NCT00883844 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2013-04-19

No results posted yet for this study

Summary

Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies investigating whether the effect of lowering viral load with nucleoside analogue therapy prior to the initiation of peginterferon results in higher sustained off-treatment responses showed contradictory findings.

The aim of this study is to investigate sustained off-treatment response to peginterferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load

Conditions

Interventions

DRUG

Nucleos(t)ide analogue treatment with a peginterferon add-on strategy

peginterferon 1.5 microgram/kg once a week Treatment with one of the approved nucleos(t)ide analogues

DRUG

Nucleos(t)ide analogue treatment

Treatment with one of the approved nucleos(t)ide analogues

Sponsors & Collaborators

  • Foundation for Liver Research

    lead OTHER

Principal Investigators

  • Harry LA Janssen, MD PhD · Erasmus MC, University Medical Center Rotterdam

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
2009-04-30
Primary Completion
2012-06-30
Completion
2012-08-31

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 NCT00883844 on ClinicalTrials.gov