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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 (PADD-ON)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Johannes Gutenberg University Mainz
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Peter R. Galle, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01524679
First received: January 31, 2012
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B
Drug: Pegylated interferon alfa-2a plus nucleos(t)ide(s)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 in Addition to an Ongoing Nucelos(t)Ide Based Treatment on Quantitative HBsAg Levels in Patients With Chronic HBeAg-negative Hepatitis B

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Difference in percentage of patients between treatment and comparator arm reaching a ≥ 1log10 decline of quantitative HBsAg after 48 weeks [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Difference in percentage of patients between treatment and comparator arm reaching a ≥ 1log10 decline of quantitative HBsAg after 48 weeks


Secondary Outcome Measures:
  • Decline of quantitative HBs antigen at week 12 and 24 [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    Decline of quantitative HBs antigen at week 12 and 24


Estimated Enrollment: 170
Study Start Date: August 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 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)
Other Name: Pegasys®
No Intervention: Control group
ongoing nucleos(t)ide based treatment alone

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524679

Contacts
Contact: Peter R Galle, Univ.-Prof. Dr. med. +49 6131 17 ext 7275 peter.galle@unimedizin-mainz.de
Contact: Annette Grambihler, Dr. med. +49 6131 17 ext 6075 annette.grambihler@unimedizin-mainz.de

Locations
Germany
Universitätsklinikum Aachen, Medizinische Klinik III Recruiting
Aachen, Germany, 52074
Contact: Frank Tacke, PD Dr. med.    +49 241 808 ext 0860    ftacke@ukaachen.de   
Charité Campus Virchow Klinikum, Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Eckart Schott, Prof.Dr.med.    +49 30 450553 ext 199    eckart.schott@charite.de   
Leber- und Studienzentrum am Checkpoint Recruiting
Berlin, Germany, 10969
Contact: Renate Heyne, Dr. med.    +49 30 259 30 ext 6470    heyne@leberzentrum-checkpoint.de   
Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn Recruiting
Bonn, Germany, 53105
Contact: Ulrich Spengler, Prof.Dr.med.    +49 228 287 ext 6789    spengler@ukb.uni-bonn.de   
Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener Recruiting
Düsseldorf, Germany, 40237
Contact: Christoph Athmann, Dr. med.    +49 211 239 ext 5520    christoph.athmann@center-duesseldorf.de   
Medizinische Klinik I, Klinik der J.W. Goethe Universität Recruiting
Frankfurt, Germany, 60590
Contact: Stefan Zeuzem, Prof.Dr.med.    +49 69 6301 ext 5212    zeuzem@em.uni-frankfurt.de   
Teuber Consulting & Research KG Recruiting
Frankfurt, Germany, 60594
Contact: Gerlinde Teuber, PD Dr. med.    +49 0172 ext 6062623    gerlinde.teuber@t-online.de   
Universitätsklinikum Freiburg Innere Medizin II Recruiting
Freiburg, Germany, 79106
Contact: Robert Thimme, Prof. Dr. med.    +49 761 270 ext 34010    robert-thimme@uniklinik-freiburg.de   
Universitätsklinikum Gießen und Marburg GmbH Recruiting
Gießen, Germany, 35392
Contact: Jürgen Lohmeyer, Prof. Dr. med.    +49 641 985 ext 57065    thomas.discher@innere.med.uni-giessen.de   
Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik Terminated
Hamburg, Germany, 20246
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie Recruiting
Hannover, Germany, 30625
Contact: Markus Cornberg, PD Dr. med.    +49 511 532 ext 2730    cornberg.markus@mh-hannover.de   
Universitätsklinikum Heidelberg, Medizinische Klinik IV Recruiting
Heidelberg, Germany, 69120
Contact: Christoph Eisenbach, PD Dr. med.    +49 6221 56 ext 8388    christoph.eisenbach@med.uni-heidelberg.de   
Universitätsklinikum des Saarlandes Recruiting
Homburg, Germany, 66421
Contact: Frank Lammert, Prof. Dr.    +49 6841 16 ext 23577    karen.schneider@uks.eu   
Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin Recruiting
Kiel, Germany, 24105
Contact: Perdita Wietzke-Braun, PD Dr. med.    +49 431 5971 ext 393      
Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln Recruiting
Köln, Germany, 50937
Contact: Tobias Goeser, Prof. Dr. med.    +49 221 478 ext 7334    tgoeser-studien@uk-koeln.de   
Universitätsklinikum Leipzig AöR Recruiting
Leipzig, Germany, 04103
Contact: Thomas Berg, Prof. Dr. med.    +49 341 97 ext 12330    thomas.berg@medizin.uni-leipzig.de   
Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik Recruiting
Mainz, Germany, 55131
Contact: Peter R Galle, Univ.-Prof.Dr.med.    +49 6131 17 ext 7275    Peter.Galle@unimedizin-mainz.de   
Universitätsklinikum Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Matthias Ebert, Prof. Dr. med.    +49 621 383 ext 3284    sekretariat.med2@umm.de   
Klinikum rechts der Isar der Technischen Universität München Recruiting
München, Germany, 81675
Contact: Fabian Geisler, PD Dr. med.    +49 89 4140 ext 5972    fabian.geisler@lrz.tum.de   
Universitätsklinikum Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Ana P Barreiros, PD    +49 941 ext 9447030    Ana.Barreiros@ukr.de   
Uniklinik Tübingen Innere Medizin Abt. I Recruiting
Tübingen, Germany, 72076
Contact: Christoph Berg, PD Dr. med.    +49 7071 2982 ext 723    christoph.berg@med.uni-tuebingen.de   
Universitätsklinikum Ulm, Zentrum für Innere Medizin Recruiting
Ulm, Germany, 89081
Contact: Dietmar Klass, Dr. med.    +49 731 500 ext 44609    dietmar.klass@uniklinik-ulm.de   
Klinikum der Universität Würzburg Zentrum für Innere Medizin (ZIM) Medizinische Klinik und Poliklinik II Leber- und Infektionsambulanz Recruiting
Würzburg, Germany, 97080
Contact: Hartwig Klinker, Prof. Dr. med.    +49 931 201 ext 40080    klinker_H@ukw.de   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Roche Pharma AG
Investigators
Principal Investigator: Peter R. Galle, Univ.-Prof. Dr. med. I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
  More Information

No publications provided

Responsible Party: Peter R. Galle, Univ.-Prof. Dr. med., Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01524679     History of Changes
Other Study ID Numbers: ML 27787
Study First Received: January 31, 2012
Last Updated: November 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johannes Gutenberg University Mainz:
chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2a
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014