Clinical trial NCT01524679: Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis B
Keywords: chronic hepatitis B
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2012-02-02
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in Quantitative HBs Antigen at Week 12
timeFrame: week 12
measure: Change in Quantitative HBs Antigen at Week 24
timeFrame: week 24
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: Facharztpraxis Prof. Löhr
state: Hessen
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, Medizinische Klinik III
city: Berlin
country: Germany
facility: Leber- und Studienzentrum am Checkpoint
city: Berlin
country: Germany
facility: Charité Campus Virchow Klinikum, Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn
city: Düsseldorf
country: Germany
facility: Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener
city: Frankfurt
country: Germany
facility: Medizinische Klinik I, Klinik der J.W. Goethe Universität
city: Frankfurt
country: Germany
facility: Teuber Consulting & Research KG
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg Innere Medizin II
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg, Medizinische Klinik IV
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Kiel
country: Germany
facility: Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin
city: Köln
country: Germany
facility: Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Tübingen
country: Germany
facility: Uniklinik Tübingen Innere Medizin Abt. I
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm, Zentrum für Innere Medizin
city: Würzburg
country: Germany
facility: Klinikum der Universität Würzburg Zentrum für Innere Medizin (ZIM) Medizinische Klinik und Poliklinik II Leber- und Infektionsambulanz
Study officials:
affiliation: I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
name: Peter R. Galle, Univ.-Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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