Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen

Chronic Hepatitis B Clinical Trial

— PADD-ON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524679
• Other study ID #: ML 27787
• Status: Completed
• Phase: Phase 2
• Start date: August 2012
• Est. completion date: August 28, 2017

Study information

• Verified date: February 2020
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: August 28, 2017
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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)

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen, Medizinische Klinik III	Aachen
Germany	Charité Campus Virchow Klinikum, Universitätsmedizin Berlin	Berlin
Germany	Leber- und Studienzentrum am Checkpoint	Berlin
Germany	Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn	Bonn
Germany	Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener	Düsseldorf
Germany	Medizinische Klinik I, Klinik der J.W. Goethe Universität	Frankfurt
Germany	Teuber Consulting & Research KG	Frankfurt
Germany	Universitätsklinikum Freiburg Innere Medizin II	Freiburg
Germany	Universitätsklinikum Gießen und Marburg GmbH	Gießen
Germany	Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik	Hamburg
Germany	Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie	Hannover
Germany	Universitätsklinikum Heidelberg, Medizinische Klinik IV	Heidelberg
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin	Kiel
Germany	Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln	Köln
Germany	Universitätsklinikum Leipzig AöR	Leipzig
Germany	Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik	Mainz
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	Klinikum rechts der Isar der Technischen Universität München	München
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Uniklinik Tübingen Innere Medizin Abt. I	Tübingen
Germany	Universitätsklinikum Ulm, Zentrum für Innere Medizin	Ulm
Germany	Facharztpraxis Prof. Löhr	Wiesbaden	Hessen
Germany	Klinikum der Universität Würzburg Zentrum für Innere Medizin (ZIM) Medizinische Klinik und Poliklinik II Leber- und Infektionsambulanz	Würzburg

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	Roche Pharma AG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a = 1log10 Decline of Quantitative HBsAg After 48 Weeks	Difference in percentage of patients between treatment and comparator arm reaching a = 1log10 decline (tenfold reduction) of quantitative HBsAg after 48 weeks	48 weeks
Secondary	Change in Quantitative HBs Antigen at Week 12	Change in quantitative HBs antigen at week 12. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome.	week 12
Secondary	Change in Quantitative HBs Antigen at Week 24	Change in quantitative HBs antigen at week 24. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome.	week 24