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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)

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Pegylated interferon alfa-2a plus nucleos(t)ide(s)
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring chronic hepatitis B

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Facharztpraxis Prof. Löhr
  • Universitätsklinikum Aachen, Medizinische Klinik III
  • Leber- und Studienzentrum am Checkpoint
  • Charité Campus Virchow Klinikum, Universitätsmedizin Berlin
  • Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn
  • Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener
  • Medizinische Klinik I, Klinik der J.W. Goethe Universität
  • Teuber Consulting & Research KG
  • Universitätsklinikum Freiburg Innere Medizin II
  • Universitätsklinikum Gießen und Marburg GmbH
  • Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik
  • Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
  • Universitätsklinikum Heidelberg, Medizinische Klinik IV
  • Universitätsklinikum des Saarlandes
  • Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin
  • Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln
  • Universitätsklinikum Leipzig AöR
  • Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik
  • Universitätsklinikum Mannheim
  • Klinikum rechts der Isar der Technischen Universität München
  • Universitätsklinikum Regensburg
  • Uniklinik Tübingen Innere Medizin Abt. I
  • Universitätsklinikum Ulm, Zentrum für Innere Medizin
  • Klinikum der Universität Würzburg Zentrum für Innere Medizin (ZIM) Medizinische Klinik und Poliklinik II Leber- und Infektionsambulanz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment group

Control group

Arm Description

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

ongoing nucleos(t)ide based treatment alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Quantitative HBs Antigen at 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.
Change in Quantitative HBs Antigen at 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.

Full Information

First Posted
January 31, 2012
Last Updated
February 5, 2020
Sponsor
Johannes Gutenberg University Mainz
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT01524679
Brief Title
Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen
Acronym
PADD-ON
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 Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 28, 2017 (Actual)
Study Completion Date
August 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
chronic hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
ongoing nucleos(t)ide based treatment alone
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon alfa-2a plus nucleos(t)ide(s)
Other Intervention Name(s)
Pegasys®
Intervention Description
Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)
Primary Outcome Measure Information:
Title
Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks
Description
Difference in percentage of patients between treatment and comparator arm reaching a ≥ 1log10 decline (tenfold reduction) of quantitative HBsAg after 48 weeks
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Change in Quantitative HBs Antigen at Week 12
Description
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.
Time Frame
week 12
Title
Change in Quantitative HBs Antigen at Week 24
Description
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.
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter R. Galle, Univ.-Prof. Dr. med.
Organizational Affiliation
I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Facharztpraxis Prof. Löhr
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65185
Country
Germany
Facility Name
Universitätsklinikum Aachen, Medizinische Klinik III
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Leber- und Studienzentrum am Checkpoint
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Charité Campus Virchow Klinikum, Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener
City
Düsseldorf
ZIP/Postal Code
40237
Country
Germany
Facility Name
Medizinische Klinik I, Klinik der J.W. Goethe Universität
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Teuber Consulting & Research KG
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
Universitätsklinikum Freiburg Innere Medizin II
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Heidelberg, Medizinische Klinik IV
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universität München
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Uniklinik Tübingen Innere Medizin Abt. I
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm, Zentrum für Innere Medizin
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Klinikum der Universität Würzburg Zentrum für Innere Medizin (ZIM) Medizinische Klinik und Poliklinik II Leber- und Infektionsambulanz
City
Würzburg
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background

Learn more about this trial

Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen

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