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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)

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ClinicalTrials.gov Identifier: NCT01524679
Recruitment Status : Active, not recruiting
First Posted : February 2, 2012
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

January 31, 2012
February 2, 2012
August 22, 2017
August 2012
August 2017   (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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: None (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
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
170
December 2017
August 2017   (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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01524679
ML 27787
No
Not Provided
Not Provided
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
August 2017

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