Status:
COMPLETED
Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen
Lead Sponsor:
Johannes Gutenberg University Mainz
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based tr...
Eligibility Criteria
Inclusion
- Chronic hepatitis B, HBe antigen negative
- treatment with a stable oral antiviral treatment (not containing telbivudine) and a fully suppressed viral load for at least 12 months (below limit of detection in conventional HBV-PCR assays, i.e. \<116 IU / ml).
- 18-70 ys
- willingness and ability to give informed consent and to follow study procedures
- willingness to use adequate contraception
Exclusion
- contraindications against treatment with pegylated interferon, e.g. depression, uncontrolled epilepsy, autoimmune diseases, pregnancy, leukocytopenia or thrombocytopenia at screening, etc.
- active alcohol or drug abuse
- preexisting polyneuropathy
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2017
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01524679
Start Date
August 1 2012
End Date
August 28 2017
Last Update
February 18 2020
Active Locations (24)
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1
Facharztpraxis Prof. Löhr
Wiesbaden, Hesse, Germany, 65185
2
Universitätsklinikum Aachen, Medizinische Klinik III
Aachen, Germany, 52074
3
Leber- und Studienzentrum am Checkpoint
Berlin, Germany, 10969
4
Charité Campus Virchow Klinikum, Universitätsmedizin Berlin
Berlin, Germany, 13353