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

Phase 2

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Pegylated interferon alfa-2a plus nucleos(t)ide(s)

• Registration Number: NCT01524679
• Lead Sponsor: Johannes Gutenberg University Mainz

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-02
• Study Start: 2012-08
• Primary Completion: 2017-08-28
• Study Completion: 2017-08-28
• Results First Submitted: 2018-08-28
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-05
• Last Update Submitted: 2020-02-05
• Results First Posted: 2020-02-18
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Pegylated interferon alfa-2a plus nucleos(t)ide(s)	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

Primary Outcome Measures

Name	Time	Method
Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks	48 weeks	Difference in percentage of patients between treatment and comparator arm reaching a ≥ 1log10 decline (tenfold reduction) of quantitative HBsAg after 48 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Quantitative HBs Antigen at Week 12	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.
Change in Quantitative HBs Antigen at Week 24	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.

Trial Locations

Locations (24)

Universitätsklinikum Ulm, Zentrum für Innere Medizin; 🇩🇪 Ulm, Germany

Klinikum der Universität Würzburg Zentrum für Innere Medizin (ZIM) Medizinische Klinik und Poliklinik II Leber- und Infektionsambulanz; 🇩🇪 Würzburg, Germany

Universitätsklinikum Aachen, Medizinische Klinik III; 🇩🇪 Aachen, Germany

Uniklinik Tübingen Innere Medizin Abt. I; 🇩🇪 Tübingen, Germany

Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik; 🇩🇪 Hamburg, Germany

Medizinische Klinik I, Klinik der J.W. Goethe Universität; 🇩🇪 Frankfurt, Germany

Universitätsklinikum Gießen und Marburg GmbH; 🇩🇪 Gießen, Germany

Universitätsklinikum Leipzig AöR; 🇩🇪 Leipzig, Germany

Facharztpraxis Prof. Löhr; 🇩🇪 Wiesbaden, Hessen, Germany

Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn; 🇩🇪 Bonn, Germany

Leber- und Studienzentrum am Checkpoint; 🇩🇪 Berlin, Germany

Charité Campus Virchow Klinikum, Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener; 🇩🇪 Düsseldorf, Germany

Universitätsklinikum Freiburg Innere Medizin II; 🇩🇪 Freiburg, Germany

Teuber Consulting & Research KG; 🇩🇪 Frankfurt, Germany

Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie; 🇩🇪 Hannover, Germany

Universitätsklinikum Heidelberg, Medizinische Klinik IV; 🇩🇪 Heidelberg, Germany

Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin; 🇩🇪 Kiel, Germany

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Germany

Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln; 🇩🇪 Köln, Germany

Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik; 🇩🇪 Mainz, Germany

Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 München, Germany

Universitätsklinikum Mannheim; 🇩🇪 Mannheim, Germany

Universitätsklinikum Regensburg; 🇩🇪 Regensburg, Germany