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 2014 by Johannes Gutenberg University Mainz
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Peter R. Galle, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01524679
First received: January 31, 2012
Last updated: March 17, 2014
Last verified: March 2014

January 31, 2012
March 17, 2014
August 2012
November 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01524679 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic 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®
  • 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
    Intervention: Drug: Pegylated interferon alfa-2a plus nucleos(t)ide(s)
  • No Intervention: Control group
    ongoing nucleos(t)ide based treatment alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Peter R Galle, Univ.-Prof. Dr. med. +49 6131 17 ext 7275 peter.galle@unimedizin-mainz.de
Contact: Annette Grambihler, Dr. med. +49 6131 17 ext 6075 annette.grambihler@unimedizin-mainz.de
Germany
 
NCT01524679
ML 27787
No
Peter R. Galle, Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
Roche Pharma AG
Principal Investigator: Peter R. Galle, Univ.-Prof. Dr. med. I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
Johannes Gutenberg University Mainz
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP