Journal of Clinical Trials
Open Access

Annette Grambihler

Publications

• Protocol Article
  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)
  
  Author(s): Martin F Sprinzl, Annette Grambihler, Jens M. Kittner, Daniel Wachtlin, Christian Ruckes, Jörn Schattenberg, Anne Ehrlich, Ulrich Alshuth, Marcus Wörns, Marcus Schuchmann and Peter R Galle Martin F Sprinzl, Annette Grambihler, Jens M. Kittner, Daniel Wachtlin, Christian Ruckes, Jörn Schattenberg, Anne Ehrlich, Ulrich Alshuth, Marcus Wörns, Marcus Schuchmann and Peter R Galle
  
  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 hepatit.. View More»
  DOI: 10.4172/2167-0870.1000226

  Abstract

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