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 2013 by Johannes Gutenberg University Mainz

Sponsor:

Collaborator:

Roche Pharma AG

Information provided by (Responsible Party):

Marcus Schuchmann, Johannes Gutenberg University Mainz

ClinicalTrials.gov Identifier:

NCT01524679

First received: January 31, 2012

Last updated: March 5, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 31, 2012

Last Updated Date

March 5, 2013

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01524679 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Hepatitis B

Intervention ^ICMJE

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®

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

170

Estimated Completion Date

August 2014

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Marcus Schuchmann, Univ.-Prof. Dr. med.	+49 6131 17 ext 7104	marcus.schuchmann@unimedizin-mainz.de
Contact: Annette Grambihler, Dr. med.	+49 6131 17 ext 6075	annette.grambihler@unimedizin-mainz.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01524679

Other Study ID Numbers ^ICMJE

ML 27787

Has Data Monitoring Committee

Responsible Party

Marcus Schuchmann, Johannes Gutenberg University Mainz

Study Sponsor ^ICMJE

Johannes Gutenberg University Mainz

Collaborators ^ICMJE

Roche Pharma AG

Investigators ^ICMJE

Principal Investigator:

Marcus Schuchmann, Univ.-Prof. Dr. med.

I. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz

Information Provided By

Johannes Gutenberg University Mainz

Verification Date

March 2013

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

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