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.
Verified March 2013 by Johannes Gutenberg University Mainz
Sponsor:
Johannes Gutenberg University Mainz
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Marcus Schuchmann, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01524679
First received: January 31, 2012
Last updated: March 5, 2013
Last verified: March 2013
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Purpose
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 Endpoint Classification: Safety/Efficacy Study 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:
Drug Information available for:
Interferon
Interferon Alfa-2a
Peginterferon Alfa-2a
Recombinant Hepatitis B vaccine
Hepatitis A Vaccines
U.S. FDA Resources
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Decline of quantitative HBs antigen at week 12 and 24
| Estimated Enrollment: | 170 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524679
Contacts
| Contact: Marcus Schuchmann, Univ.-Prof. Dr. med. | +49 6131 17 ext 7104 | marcus.schuchmann@unimedizin-mainz.de |
| Contact: Annette Grambihler, Dr. med. | +49 6131 17 ext 6075 | annette.grambihler@unimedizin-mainz.de |
Locations
| Germany | |
| Universitätsklinikum Aachen, Medizinische Klinik III | Not yet recruiting |
| Aachen, Germany, 52074 | |
| Contact: Frank Tacke, PD Dr. med. +49 241 808 ext 0860 ftacke@ukaachen.de | |
| Charité Campus Virchow Klinikum, Universitätsmedizin Berlin | Not yet recruiting |
| Berlin, Germany, 13353 | |
| Contact: Eckart Schott, Prof.Dr.med. +49 30 450553 ext 199 eckart.schott@charite.de | |
| Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn | Not yet recruiting |
| Bonn, Germany, 53105 | |
| Contact: Ulrich Spengler, Prof.Dr.med. +49 228 287 ext 6789 spengler@ukb.uni-bonn.de | |
| Medizinische Klinik I, Klinik der J.W. Goethe Universität | Not yet recruiting |
| Frankfurt, Germany, 60590 | |
| Contact: Stefan Zeuzem, Prof.Dr.med. +49 69 6301 ext 5212 zeuzem@em.uni-frankfurt.de | |
| Universitätsklinikum Gießen und Marburg GmbH | Not yet recruiting |
| Gießen, Germany, 35392 | |
| Contact: Jürgen Lohmeyer, Prof. Dr. med. +49 641 985 ext 57065 thomas.discher@innere.med.uni-giessen.de | |
| Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik | Not yet recruiting |
| Hamburg, Germany, 20246 | |
| Contact: Ansgar Lohse, Prof.Dr.med. +49 40 7410 ext 57981 sekretariatlohse@uke.de | |
| Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie | Not yet recruiting |
| Hannover, Germany, 30625 | |
| Contact: Markus Cornberg, PD Dr. med. +49 511 532 ext 2730 cornberg.markus@mh-hannover.de | |
| Universitätsklinikum Heidelberg, Medizinische Klinik IV | Not yet recruiting |
| Heidelberg, Germany, 69120 | |
| Contact: Christoph Eisenbach, PD Dr. med. +49 6221 56 ext 8388 christoph.eisenbach@med.uni-heidelberg.de | |
| Universitätsklinikum des Saarlandes | Not yet recruiting |
| Homburg, Germany, 66421 | |
| Contact: Frank Lammert, Prof. Dr. +49 6841 16 ext 23577 karen.schneider@uks.eu | |
| Universitätsklinikum Leipzig AöR | Not yet recruiting |
| Leipzig, Germany, 04103 | |
| Contact: Thomas Berg, Prof. Dr. med. +49 341 97 ext 12330 thomas.berg@medizin.uni-leipzig.de | |
| Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik | Recruiting |
| Mainz, Germany, 55131 | |
| Contact: Marcus Schuchmann, Univ.-Prof.Dr.med. +49 6131 17 ext 7104 marcus.schumann@unimedizin-mainz.de | |
| Universitätsklinikum Mannheim | Not yet recruiting |
| Mannheim, Germany, 68167 | |
| Contact: Matthias Ebert, Prof. Dr. med. +49 621 383 ext 3284 sekretariat.med2@umm.de | |
| Klinikum rechts der Isar der Technischen Universität München | Not yet recruiting |
| München, Germany, 81675 | |
| Contact: Fabian Geisler, PD Dr. med. +49 89 4140 ext 5972 fabian.geisler@lrz.tum.de | |
| Universitätsklinikum Ulm, Zentrum für Innere Medizin | Not yet recruiting |
| Ulm, Germany, 89081 | |
| Contact: Dietmar Klass, Dr. med. +49 731 500 ext 44609 dietmar.klass@uniklinik-ulm.de | |
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Roche Pharma AG
Investigators
| Principal Investigator: | Marcus Schuchmann, Univ.-Prof. Dr. med. | I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz |
More Information
No publications provided
| Responsible Party: | Marcus Schuchmann, Univ.-Prof. Dr. med., Johannes Gutenberg University Mainz |
| ClinicalTrials.gov Identifier: | NCT01524679 History of Changes |
| Other Study ID Numbers: | ML 27787 |
| Study First Received: | January 31, 2012 |
| Last Updated: | March 5, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Johannes Gutenberg University Mainz:
|
chronic hepatitis B |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic 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 Interferon-alpha |
Interferon Alfa-2a Interferons Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013