|Martin F Sprinzl1*, Annette Grambihler1, Jens M. Kittner1, Daniel Wachtlin2, Christian Ruckes2, Jörn Schattenberg1, Anne Ehrlich2, Ulrich Alshuth3, Marcus Wörns1, Marcus Schuchmann1 and Peter R Galle1|
|1First Medical Department, University Medical Center, Johannes Gutenberg University, Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany|
|2Interdisziplinäres Zentrum Klinische Studien (IZKS), University Medical Center, Johannes Gutenberg University, Langenbeckstraße 1, 55131 Mainz, Germany|
|3Roche Pharma AG, Medical Information, Emil-Barrell-Str.1, 79639 Grenzach-Wyhlen, Germany|
|Corresponding Author :||Martin F Sprinzl (MD)
First Medical Department, University Medical Center
Johannes Gutenberg University, Mainz
Langenbeckstrasse 1, 55131 Mainz, Germany
|Received June 01, 2015; Accepted June 26, 2015; Published June 28, 2015|
|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|
|Copyright: © 2015 Sprinzl MF, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
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Background: Hepatitis B surface antigen (HBsAg) clearance marks the prime event of HBV elimination in chronic hepatitis B and is associated with better overall outcome. Despite reliable viral suppression under standard treatment with nucleos(t)ide analogues (NUCs) the goal of HBsAg clearance is rarely achieved. Also synchronous combination of NUCs with pegylated interferon-α-2a (peg-IFNα) has not been superior compared to peg-IFNα monotherapy in prospective randomized trials. However, sequential addition of peg-IFNα to an ongoing NUC regimen has provided higher HBsAg clearance rates in uncontrolled pilot studies.
Methods/Design: In this protocol we investigate the sequential addition of open-label peg-IFNα for 48 weeks to an ongoing NUC regimen following patients written informed consent. Included are patients with HBeAg negative chronic hepatitis B and a suppressed HBV DNA (<20 IU/mL) for a minimum of 12 months under NUCs prior to trial enrollment. Patients are randomized (2:1 ratio) to peg-IFNα add-on/ NUC treatment or a control group receiving continuous NUCs only. Patients are followed regularly during the trial intervention including a per protocol follow-up for 24 weeks after end of treatment. The primary endpoint is the objective response after 48 weeks of combination therapy, defined by a confirmed reduction of HBsAg by ≥ 1log10 IU/mL compared to baseline. Secondary endpoints are the HBsAg seroconversion rate, safety and tolerability of the IFN add-on therapy regimen. The trial was approved by the local ethic committees of all participating study sites.
Trial registration: The trial was registered on the 10th of June 2011 at EudraCT (ID number 2011-002812-10).