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

NCT ID: NCT01524679

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2017-08-28

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.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)

Control group

ongoing nucleos(t)ide based treatment alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)

Intervention Type: DRUG

Other Intervention Names

Pegasys®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Peter R. Galle

Univ.-Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter R. Galle, Univ.-Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz

Locations

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

Universitätsklinikum Gießen und Marburg GmbH

Giessen, , Germany

Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik

Hamburg, , Germany

Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie

Hanover, , Germany

Universitätsklinikum Heidelberg, Medizinische Klinik IV

Heidelberg, , Germany

Universitätsklinikum des Saarlandes

Homburg, , Germany

Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin

Kiel, , Germany

Universitätsklinikum Leipzig AöR

Leipzig, , Germany

Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik

Mainz, , Germany

Universitätsklinikum Mannheim

Mannheim, , Germany

Klinikum rechts der Isar der Technischen Universität München

München, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Uniklinik Tübingen Innere Medizin Abt. I

Tübingen, , Germany

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

Countries

Germany

References

Sprinzl MF, Grambihler A, Kittner JM, Wachtlin D, Ruckes C, et al. (2015) Prospective Randomized Open-label Trial Protocol Investigating the Addition of Pegylated Interferon-alpha to an Ongoing Nucleos(t)ide Treatment Regimen of HBeAg Negative Chronic Hepatitis B Patients (PADD-ON). J Clin Trials 5: 226. doi:10.4172/2167-0870.1000226

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ML 27787

Identifier Type: -

Identifier Source: org_study_id