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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)

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ClinicalTrials.gov Identifier: NCT01524679
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Peter R. Galle, 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.


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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2012
Actual Primary Completion Date : August 28, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524679


Locations
Germany
Facharztpraxis Prof. Löhr
Wiesbaden, Hessen, Germany, 65185
Universitätsklinikum Aachen, Medizinische Klinik III
Aachen, Germany, 52074
Leber- und Studienzentrum am Checkpoint
Berlin, Germany, 10969
Charité Campus Virchow Klinikum, Universitätsmedizin Berlin
Berlin, Germany, 13353
Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn
Bonn, Germany, 53105
Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener
Düsseldorf, Germany, 40237
Medizinische Klinik I, Klinik der J.W. Goethe Universität
Frankfurt, Germany, 60590
Teuber Consulting & Research KG
Frankfurt, Germany, 60594
Universitätsklinikum Freiburg Innere Medizin II
Freiburg, Germany, 79106
Universitätsklinikum Gießen und Marburg GmbH
Gießen, Germany, 35392
Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik
Hamburg, Germany, 20246
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
Hannover, Germany, 30625
Universitätsklinikum Heidelberg, Medizinische Klinik IV
Heidelberg, Germany, 69120
Universitätsklinikum des Saarlandes
Homburg, Germany, 66421
Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin
Kiel, Germany, 24105
Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln
Köln, Germany, 50937
Universitätsklinikum Leipzig AöR
Leipzig, Germany, 04103
Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik
Mainz, Germany, 55131
Universitätsklinikum Mannheim
Mannheim, Germany, 68167
Klinikum rechts der Isar der Technischen Universität München
München, Germany, 81675
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Uniklinik Tübingen Innere Medizin Abt. I
Tübingen, Germany, 72076
Universitätsklinikum Ulm, Zentrum für Innere Medizin
Ulm, Germany, 89081
Klinikum der Universität Würzburg Zentrum für Innere Medizin (ZIM) Medizinische Klinik und Poliklinik II Leber- und Infektionsambulanz
Würzburg, Germany, 97080
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

Publications:
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
ClinicalTrials.gov Identifier: NCT01524679     History of Changes
Other Study ID Numbers: ML 27787
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Peter R. Galle, Johannes Gutenberg University Mainz:
chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
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
Interferons
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs