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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 2015 by Johannes Gutenberg University Mainz
Roche Pharma AG
Information provided by (Responsible Party):
Peter R. Galle, Johannes Gutenberg University Mainz Identifier:
First received: January 31, 2012
Last updated: November 30, 2015
Last verified: November 2015

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
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 ]
    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 ]
    Decline of quantitative HBs antigen at week 12 and 24

Estimated Enrollment: 170
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01524679

Contact: Peter R Galle, Univ.-Prof. Dr. med. +49 6131 17 ext 7275
Contact: Annette Grambihler, Dr. med. +49 6131 17 ext 6075

Facharztpraxis Prof. Löhr Recruiting
Wiesbaden, Hessen, Germany, 65185
Contact: Hanns Löhr, Prof. Dr. med.    0049 (0)611 ext 377911   
Universitätsklinikum Aachen, Medizinische Klinik III Recruiting
Aachen, Germany, 52074
Contact: Frank Tacke, PD Dr. med.    +49 241 808 ext 0860   
Leber- und Studienzentrum am Checkpoint Recruiting
Berlin, Germany, 10969
Contact: Renate Heyne, Dr. med.    +49 30 259 30 ext 6470   
Charité Campus Virchow Klinikum, Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Contact: Eckart Schott,    +49 30 450553 ext 199   
Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn Recruiting
Bonn, Germany, 53105
Contact: Ulrich Spengler,    +49 228 287 ext 6789   
Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener Recruiting
Düsseldorf, Germany, 40237
Contact: Christoph Athmann, Dr. med.    +49 211 239 ext 5520   
Medizinische Klinik I, Klinik der J.W. Goethe Universität Recruiting
Frankfurt, Germany, 60590
Contact: Stefan Zeuzem,    +49 69 6301 ext 5212   
Teuber Consulting & Research KG Recruiting
Frankfurt, Germany, 60594
Contact: Gerlinde Teuber, PD Dr. med.    +49 0172 ext 6062623   
Universitätsklinikum Freiburg Innere Medizin II Recruiting
Freiburg, Germany, 79106
Contact: Robert Thimme, Prof. Dr. med.    +49 761 270 ext 34010   
Universitätsklinikum Gießen und Marburg GmbH Recruiting
Gießen, Germany, 35392
Contact: Jürgen Lohmeyer, Prof. Dr. med.    +49 641 985 ext 57065   
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   
Universitätsklinikum Heidelberg, Medizinische Klinik IV Recruiting
Heidelberg, Germany, 69120
Contact: Anita Pathil-Warth, Dr. med.    +49 6221 56 ext 8388   
Universitätsklinikum des Saarlandes Recruiting
Homburg, Germany, 66421
Contact: Frank Lammert, Prof. Dr.    +49 6841 16 ext 23577   
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   
Universitätsklinikum Leipzig AöR Recruiting
Leipzig, Germany, 04103
Contact: Thomas Berg, Prof. Dr. med.    +49 341 97 ext 12330   
Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik Recruiting
Mainz, Germany, 55131
Contact: Peter R Galle,    +49 6131 17 ext 7275   
Universitätsklinikum Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Matthias Ebert, Prof. Dr. med.    +49 621 383 ext 3284   
Klinikum rechts der Isar der Technischen Universität München Recruiting
München, Germany, 81675
Contact: Fabian Geisler, PD Dr. med.    +49 89 4140 ext 5972   
Universitätsklinikum Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Kilian Weigand, PD    +49 941 944 7030   
Uniklinik Tübingen Innere Medizin Abt. I Recruiting
Tübingen, Germany, 72076
Contact: Christoph Berg, PD Dr. med.    +49 7071 2982 ext 723   
Universitätsklinikum Ulm, Zentrum für Innere Medizin Recruiting
Ulm, Germany, 89081
Contact: Matthias Dollinger, PD Dr. med.    +49 731 500 ext 44609   
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   
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Roche Pharma AG
Principal Investigator: Peter R. Galle, Univ.-Prof. Dr. med. I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
  More Information

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

Responsible Party: Peter R. Galle, Univ.-Prof. Dr. med., Johannes Gutenberg University Mainz Identifier: NCT01524679     History of Changes
Other Study ID Numbers: ML 27787 
Study First Received: January 31, 2012
Last Updated: November 30, 2015

Keywords provided by Johannes Gutenberg University Mainz:
chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents processed this record on February 27, 2017