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

Johannes Gutenberg University Mainz170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Chronic Hepatitis B

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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)

Facharztpraxis Prof. Löhr

Wiesbaden, Hesse, Germany

Universitätsklinikum Aachen, Medizinische Klinik III

Aachen, Germany

Leber- und Studienzentrum am Checkpoint

Berlin, Germany

Charité Campus Virchow Klinikum, Universitätsmedizin Berlin

Berlin, Germany

Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn

Bonn, Germany

Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln

Cologne, Germany

Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener

Düsseldorf, Germany

Medizinische Klinik I, Klinik der J.W. Goethe Universität

Frankfurt, Germany

Teuber Consulting & Research KG

Frankfurt, Germany

Universitätsklinikum Freiburg Innere Medizin II

Freiburg im Breisgau, Germany

...and 14 more locations

Outcomes

Primary Outcomes

Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks

Difference in percentage of patients between treatment and comparator arm reaching a ≥ 1log10 decline (tenfold reduction) of quantitative HBsAg after 48 weeks

Time frame: 48 weeks

Secondary Outcomes

Change in Quantitative HBs Antigen at Week 12

Change in quantitative HBs antigen at week 12. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome.

Time frame: week 12

Change in Quantitative HBs Antigen at Week 24

Change in quantitative HBs antigen at week 24. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome.

Time frame: week 24