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
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
1 other identifier
interventional
170
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2012
Longer than P75 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
February 2, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2017
CompletedResults Posted
Study results publicly available
February 18, 2020
CompletedFebruary 18, 2020
February 1, 2020
5.1 years
January 31, 2012
August 28, 2018
February 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks
Difference in percentage of patients between treatment and comparator arm reaching a ≥ 1log10 decline (tenfold reduction) of quantitative HBsAg after 48 weeks
48 weeks
Secondary Outcomes (2)
Change in Quantitative HBs Antigen at Week 12
week 12
Change in Quantitative HBs Antigen at Week 24
week 24
Study Arms (2)
Treatment group
EXPERIMENTALpegylated 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
Control group
NO INTERVENTIONongoing nucleos(t)ide based treatment alone
Interventions
Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)
Eligibility Criteria
You may qualify if:
- 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).
- willingness and ability to give informed consent and to follow study procedures
- willingness to use adequate contraception
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johannes Gutenberg University Mainzlead
- Roche Pharma AGcollaborator
Study Sites (24)
Facharztpraxis Prof. Löhr
Wiesbaden, Hesse, 65185, Germany
Universitätsklinikum Aachen, Medizinische Klinik III
Aachen, 52074, Germany
Leber- und Studienzentrum am Checkpoint
Berlin, 10969, Germany
Charité Campus Virchow Klinikum, Universitätsmedizin Berlin
Berlin, 13353, Germany
Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn
Bonn, 53105, Germany
Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln
Cologne, 50937, Germany
Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener
Düsseldorf, 40237, Germany
Medizinische Klinik I, Klinik der J.W. Goethe Universität
Frankfurt, 60590, Germany
Teuber Consulting & Research KG
Frankfurt, 60594, Germany
Universitätsklinikum Freiburg Innere Medizin II
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, 35392, Germany
Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik
Hamburg, 20246, Germany
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
Hanover, 30625, Germany
Universitätsklinikum Heidelberg, Medizinische Klinik IV
Heidelberg, 69120, Germany
Universitätsklinikum des Saarlandes
Homburg, 66421, Germany
Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin
Kiel, 24105, Germany
Universitätsklinikum Leipzig AöR
Leipzig, 04103, Germany
Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik
Mainz, 55131, Germany
Universitätsklinikum Mannheim
Mannheim, 68167, Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
Universitätsklinikum Regensburg
Regensburg, 93053, Germany
Uniklinik Tübingen Innere Medizin Abt. I
Tübingen, 72076, Germany
Universitätsklinikum Ulm, Zentrum für Innere Medizin
Ulm, 89081, Germany
Klinikum der Universität Würzburg Zentrum für Innere Medizin (ZIM) Medizinische Klinik und Poliklinik II Leber- und Infektionsambulanz
Würzburg, 97080, Germany
Related Publications (1)
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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christian Ruckes
- Organization
- IZKS of the University Medical Center of the Johannes Gutenberg University Mainz
Study Officials
- PRINCIPAL INVESTIGATOR
Peter R. Galle, Univ.-Prof. Dr. med.
I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ.-Prof. Dr. med.
Study Record Dates
First Submitted
January 31, 2012
First Posted
February 2, 2012
Study Start
August 1, 2012
Primary Completion
August 28, 2017
Study Completion
August 28, 2017
Last Updated
February 18, 2020
Results First Posted
February 18, 2020
Record last verified: 2020-02