Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Treatment to Ncrease Sustained Response in CHB
NCT01532843 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2019-01-04
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
-
PegIFN alfa-2b
Peginterferon alpha-2b 1.5 μg/kg per week s.c.for 48 weeks
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
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-06-30
- Primary Completion
- 2015-08-31
- Completion
- 2015-08-31
Countries
- China
- Netherlands
Study Locations
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