Trial record 40 of 443 for:    hepatitis b | Open Studies

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.
Verified March 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: March 17, 2014
Last verified: March 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
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 Not yet recruiting
Aachen, Germany, 52074
Contact: Frank Tacke, PD Dr. med.    +49 241 808 ext 0860    ftacke@ukaachen.de   
Charité Campus Virchow Klinikum, Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 13353
Contact: Eckart Schott, Prof.Dr.med.    +49 30 450553 ext 199    eckart.schott@charite.de   
Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn Not yet recruiting
Bonn, Germany, 53105
Contact: Ulrich Spengler, Prof.Dr.med.    +49 228 287 ext 6789    spengler@ukb.uni-bonn.de   
Medizinische Klinik I, Klinik der J.W. Goethe Universität Not yet recruiting
Frankfurt, Germany, 60590
Contact: Stefan Zeuzem, Prof.Dr.med.    +49 69 6301 ext 5212    zeuzem@em.uni-frankfurt.de   
Universitätsklinikum Gießen und Marburg GmbH Not yet 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 Not yet recruiting
Hamburg, Germany, 20246
Contact: Ansgar Lohse, Prof.Dr.med.    +49 40 7410 ext 57981    sekretariatlohse@uke.de   
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie Not yet 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 Not yet recruiting
Heidelberg, Germany, 69120
Contact: Christoph Eisenbach, PD Dr. med.    +49 6221 56 ext 8388    christoph.eisenbach@med.uni-heidelberg.de   
Universitätsklinikum des Saarlandes Not yet recruiting
Homburg, Germany, 66421
Contact: Frank Lammert, Prof. Dr.    +49 6841 16 ext 23577    karen.schneider@uks.eu   
Universitätsklinikum Leipzig AöR Not yet 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: Marcus Schuchmann, Univ.-Prof.Dr.med.    +49 6131 17 ext 7104    marcus.schumann@unimedizin-mainz.de   
Universitätsklinikum Mannheim Not yet 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 Not yet recruiting
München, Germany, 81675
Contact: Fabian Geisler, PD Dr. med.    +49 89 4140 ext 5972    fabian.geisler@lrz.tum.de   
Universitätsklinikum Ulm, Zentrum für Innere Medizin Not yet recruiting
Ulm, Germany, 89081
Contact: Dietmar Klass, Dr. med.    +49 731 500 ext 44609    dietmar.klass@uniklinik-ulm.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: March 17, 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, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 23, 2014