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)

February 5, 2020 updated by: Peter R. Galle, Johannes Gutenberg University Mainz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Pegasys®
No Intervention: Control group
ongoing nucleos(t)ide based treatment alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 (tenfold reduction) of quantitative HBsAg after 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quantitative HBs Antigen at Week 12
Time Frame: week 12
Change in quantitative HBs antigen at week 12. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome.
week 12
Change in Quantitative HBs Antigen at Week 24
Time Frame: week 24
Change in quantitative HBs antigen at week 24. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome.
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Peter R. Galle, Univ.-Prof. Dr. med., I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 28, 2017

Study Completion (Actual)

August 28, 2017

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

January 31, 2012

First Posted (Estimate)

February 2, 2012

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML 27787

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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