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Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen

NCT01524679

CompletedPhase 2

Sponsor: Johannes Gutenberg University Mainz

Conditions: Chronic Hepatitis B

Interventions: Pegylated interferon alfa-2a plus nucleos(t)ide(s)

Countries: Germany

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 treatment in patients with chronic HBeAg-negative hepatitis B The primary objective of the trial is to investigate whether the add-on of pegylated interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48 weeks. 170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an oral antiviral regimen and having a nondetectable viral load for at least 12 months are included.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (24)

Wiesbaden, Hesse, Germany
Aachen, Germany
Berlin, Germany
Berlin, Germany
Bonn, Germany
Cologne, Germany
Düsseldorf, Germany
Frankfurt, Germany
Frankfurt, Germany
Freiburg im Breisgau, Germany
Giessen, Germany
Hamburg, Germany
Hanover, Germany
Heidelberg, Germany
Homburg, Germany
Kiel, Germany
Leipzig, Germany
Mainz, Germany
Mannheim, Germany
München, Germany
Regensburg, Germany
Tübingen, Germany
Ulm, Germany
Würzburg, Germany