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AzTrials

Chronic Hepatitis BPhase 2PADD-ONNCT01524679

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

A Phase 2 study testing Pegylated interferon alfa-2a plus nucleos(t)ide(s) in people with Chronic Hepatitis B, run by Johannes Gutenberg University Mainz at 24 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
Pegylated interferon alfa-2a plus nucleos(t)ide(s)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
24 sitesGermany
Study dates
Aug 2012to 28 Aug 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Germany24 sites

  • Universitätsklinikum Aachen, Medizinische Klinik III

    Aachen, 52074

  • Leber- und Studienzentrum am Checkpoint

    Berlin, 10969

  • Charité Campus Virchow Klinikum, Universitätsmedizin Berlin

    Berlin, 13353

  • Medizinische Klinik und Poliklinik I, Universitätsklinik Bonn

    Bonn, 53105

  • Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum Universitätsklinikum Köln

    Cologne, 50937

  • Medizinisches Versorgungszentrum Dr. Mauss, Schmutz, Dr. Athmann, Dr. Hegener

    Düsseldorf, 40237

  • Medizinische Klinik I, Klinik der J.W. Goethe Universität

    Frankfurt, 60590

  • Teuber Consulting & Research KG

    Frankfurt, 60594

  • Universitätsklinikum Freiburg Innere Medizin II

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35392

  • Universitätsklinikum Hamburg-Eppendorf, I. Med. Klinik und Poliklinik

    Hamburg, 20246

  • Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie

    Hanover, 30625

  • Universitätsklinikum Heidelberg, Medizinische Klinik IV

    Heidelberg, 69120

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Universitätsklinik Schleswig-Holstein Campus Kiel Klinik für Allgemeine Innere Medizin

    Kiel, 24105

  • Universitätsklinikum Leipzig AöR

    Leipzig, 04103

  • Universitätsmedizin Mainz, I. Med. Klinik und Poliklinik

    Mainz, 55131

  • Universitätsklinikum Mannheim

    Mannheim, 68167

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Uniklinik Tübingen Innere Medizin Abt. I

    Tübingen, 72076

  • Universitätsklinikum Ulm, Zentrum für Innere Medizin

    Ulm, 89081

  • Facharztpraxis Prof. Löhr

    Wiesbaden, Hesse, 65185

  • Klinikum der Universität Würzburg Zentrum für Innere Medizin (ZIM) Medizinische Klinik und Poliklinik II Leber- und Infektionsambulanz

    Würzburg, 97080

Other trials in Germany

About this study

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

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.

Being tested
Pegylated interferon alfa-2a plus nucleos(t)ide(s)
Keywords
chronic hepatitis B
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pegylated interferon alfa-2a plus nucleos(t)ide(s)Drug

    Also called Pegasys®

    Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)

Study groups in NCT01524679
Study groupRoleWhat they receive
Treatment groupExperimentalpegylated 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
Receives: Drug: Pegylated interferon alfa-2a plus nucleos(t)ide(s)
Control groupNo interventionongoing nucleos(t)ide based treatment alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 48 weeks

Secondary outcomes (2)

  1. 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.

    Measured: week 12

  2. 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.

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2012 (estimated)
  2. Study startAug 2012
  3. Primary completion28 Aug 2017
  4. Study completion28 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01524679
Sponsor's protocol ID
ML 27787
Acronym
PADD-ON
Status last verified
Feb 2020
First submitted
31 Jan 2012
Last updated
18 Feb 2020
Data monitoring committee
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegylated interferon alfa-2a plus nucleos(t)ide(s) in people with Chronic Hepatitis B, run by Johannes Gutenberg University Mainz at 24 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01524679, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.

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