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Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection

27. Mai 2026 aktualisiert von: Ole Schmeltz Søgaard, Aarhus University Hospital

Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection (the SAMBA-D Study)

Hepatitis D virus (HDV) is a major global health issue, with an estimated 12 million people living with the infection worldwide. HDV infection requires the presence of hepatitis B virus (HBV), as it relies on hepatitis B virus for replication within the liver cells. Treatment options for HDV are limited and cannot cure the infection. The combination of concurrent HBV and HDV increases the risk of developing severe liver disease, including cirrhosis and liver cancer. This risk would significantly decrease if HDV is eliminated or reduced. Consequently, there is a need for the development of new treatment options.

Colleagues at Rockefeller University in New York have identified the antibody HepB mAb19, which effectively reduces the amount of circulating HBV antigens. Since HDV depends on HBV to replicate, we will test this antibody as a potential treatment for HDV.

The trial design is a phase 1b open-label aiming at including 15 study participants with chronic hepatitis D infection. All study participants will receive two or three dosis of the antibody, HepB mAB19, and will be followed for 60 weeks after the first HepB mAb19 infusion.

This study will evaluate the safety and pharmacokinetics of this antibody, as well as its potential effects on viral levels of HDV RNA and antiviral immune responses in individuals living with chronic HDV infection.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

15

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Ole Schmeltz Søgaard, MD, PhD, professor
  • Telefonnummer: +45 24 77 79 95
  • E-Mail: olesoega@rm.dk

Studieren Sie die Kontaktsicherung

  • Name: Henriette Vendelbo Graversen, MD
  • Telefonnummer: +45 51 49 25 95
  • E-Mail: henrgv@rm.dk

Studienorte

  • Deutschland
      • Berlin, Deutschland
        • Noch keine Rekrutierung
        • Charité - Universitätsmedizin Berlin
        • Kontakt:
  • Dänemark
      • Aarhus, Dänemark, 8000
        • Rekrutierung
        • Aarhus University Hospital
        • Kontakt:
          • Henriette Vendelbo Graversen, MD
          • Telefonnummer: +45 51 49 25 95
          • E-Mail: henrgv@rm.dk

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • HDV infection confirmed by positive anti-HDV antibody and detectable HDV RNA
  • HBs antibody negative during screening period
  • Both HBeAg positive and negative participants are included
  • Ability and willingness to provide informed consent
  • Participants who can become pregnant must agree to use two methods of contraception:
  • Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms 10 days prior to study entry and during study follow up to avoid impregnating a partner who can get pregnant.

Exclusion Criteria:

  • Child-Turcotte-Pugh >9 points
  • Severe clinical hepatic decompensation-such as hepatic encephalopathy or variceal hemorrhage-occurring currently or within the past 12 months.
  • Any confirmed significant allergic reactions (urticaria or anaphylaxis) against monoclonal antibody or vaccine, or multiple drug allergies (non-active hay fever is acceptable)
  • Pregnancy or lactation
  • Any vaccination 2 weeks prior to entry
  • Prior receipt of HepB mAb19 therapy
  • Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness 2 weeks prior to entry
  • Active hepatitis C infection
  • Untreated HIV disease
  • Individuals with HIV receiving antiretroviral therapy who have had a measurement of plasma HIV RNA (viral load) >50 copies/mL within the past 6 months are excluded. However, a single viral load measurement between >50 and <500 copies/mL during this period is acceptable.
  • Participation in another clinical study of an investigational product currently or 12 weeks prior to entry, or expected participation during this study

Laboratory abnormalities in the parameters listed below:

  • Alpha fetoprotein >100 ng/mL
  • Hemoglobin <10 gm/dL (6.21 mmol/L)
  • Platelet count <25,000 /mm3
  • Estimated glomerular filtration rate (eGFR) <60 mL/min
  • ALT ≥ x10 upper limit of normal (ULN)

Current, or history of:

  • Clinical cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure.
  • Presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., PR interval >210 ms (1st degree AV block only if clinical symptoms are present), QT corrected for heart rate using the Fridericia's correction factor [QTcF] > 450 ms for males and QTcF >470 ms for females);
  • Chronic liver disease from another cause, ICD, or autoimmune diseases that in the opinion of the investigator would preclude participation
  • History of hematopoietic stem cell transplant or solid organ transplant

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Opel label
All participants will be included in this study arm
Arzneimittel: HepB mAb19
All participants will receive a dose of HepB mAb19 at day 0 of 10 mg/kg and at day 28 of 30 mg/kg. They will receive a third dose at day 140 of 30 mg/kg if we observe a 1-log decrease in HDV RNA from week 0 to week 6.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Safety and tolerability
Zeitfenster: Two weeks after each administration
Rate and severity of solicited adverse events that are Grade 2 or above
Two weeks after each administration
Safety and tolerability
Zeitfenster: 2, 12, 28 and 60 weeks after first HepB mAb19 administration
Rate and severity of treatment-emerging unsolicited adverse events (including confirmed laboratory abnormalities) 2, 12, 28 and 60 weeks after first HepB mAb19 administration.
2, 12, 28 and 60 weeks after first HepB mAb19 administration
Safety and tolerability
Zeitfenster: From enrollment to end of follow-up at week 60
Rate and severity of serious adverse events (SAEs) throughout the study period following investigational product (IP) administration
From enrollment to end of follow-up at week 60
Safety and tolerability
Zeitfenster: From enrollment to end of follow-up at week 60
Rate and severity of adverse events of special interest, such as immune complex disease (ICD) throughout the study period following IP administration.
From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Zeitfenster: From enrollment to end of follow-up at week 60
HepB mAb19 levels in serum will be measured by a validated sandwich ELISA method developed and performed by Celldex Therapeutics. HepB mAb19 levels will be measured before and at the end of each of the antibody administrations, at 3 and 6 hours, and at later time points during follow up.
From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Zeitfenster: From enrollment to end of follow-up at week 60
Assesment of HepB mAb19 elimination half-life (t1/2)
From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Zeitfenster: From enrollment to end of follow-up at week 60
Assesment of clearance (CL/F) of HepB mAb19
From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Zeitfenster: From enrollment to end of follow-up at week 60
Calculation of volume of distribution (Vz/F)
From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Zeitfenster: From enrollment to end of follow-up at week 60
Calculation of area under the curve (AUC) for HepB mAb19
From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Zeitfenster: From enrollment to end of follow-up at week 60
Calculation of HepB mAb19 decay curve
From enrollment to end of follow-up at week 60

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Virologic response
Zeitfenster: From baseline (day 0) to week 28
Virologic response defined as HDV RNA decrease of ≥2 log10 IU/mL or to undetectable from baseline (day 0) to week 28.
From baseline (day 0) to week 28
Anti-drug antibodies
Zeitfenster: From enrollment to end of follow-up at week 60
Rate of induced anti-HepB mAb19 antibodies.
From enrollment to end of follow-up at week 60
Changes in liver function tests
Zeitfenster: From enrollment to end of follow-up at week 60
Changes in liver function tests (e.g. ALT, AST, alkaline phosphatase, bilirubin, albumin) at selected follow-up visits.
From enrollment to end of follow-up at week 60

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
HBV markers
Zeitfenster: From enrollment to end of follow-up at week 60
  • Change in quantitative serum HBsAg levels from baseline (day 0) and from achieved nadir (lowest serum HBsAg level following IP administration) at each scheduled follow up visit.
  • HBV DNA levels at baseline and selected follow up visits
  • HBcrAg levels at baseline and selected follow up visits.
  • HBsAb conversion from negative at baseline to positive at selected follow up visits.
  • HBeAg levels at baseline and selected follow up visits.
  • HBeAb conversion from negative at baseline to positive at selected follow up visits, among participants who are seronegative at baseline.
  • HBV-specific T and B cell immune responses following HepB mAb19 administration.
From enrollment to end of follow-up at week 60
HDV markers
Zeitfenster: From enrollment to end of follow-up at week 60
- Anti-HDV at baseline and at selected follow-up visits.
From enrollment to end of follow-up at week 60
Innate immune response
Zeitfenster: From enrollment to end of study at week 60
Changes in innate immune responses following HepB mAb19 administration.
From enrollment to end of study at week 60
Changes in inflammatory markers
Zeitfenster: From enrollment to end of follow-up at week 60
Changes in inflammatory markers following HepB mAb19 administration.
From enrollment to end of follow-up at week 60
Changes in fibrosis grade
Zeitfenster: From enrollment to end of follow-up at week 60.
Changes in fibrosis grade by FibroScan from entry to end of study.
From enrollment to end of follow-up at week 60.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Aarhus University Hospital

Mitarbeiter

Charite University, Berlin, Germany

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

23. April 2026

Primärer Abschluss (Geschätzt)

1. April 2028

Studienabschluss (Geschätzt)

1. April 2028

Studienanmeldedaten

Zuerst eingereicht

12. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2026

Zuerst gepostet (Tatsächlich)

28. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SAMBA-D-001
  • 2025-522125-36-00 (Ctis)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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