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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 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

15

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Ole Schmeltz Søgaard, MD, PhD, professor
  • Numéro de téléphone: +45 24 77 79 95
  • E-mail: olesoega@rm.dk

Sauvegarde des contacts de l'étude

  • Nom: Henriette Vendelbo Graversen, MD
  • Numéro de téléphone: +45 51 49 25 95
  • E-mail: henrgv@rm.dk

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne
        • Pas encore de recrutement
        • Charité - Universitätsmedizin Berlin
        • Contact:
  • Danemark
      • Aarhus, Danemark, 8000
        • Recrutement
        • Aarhus University Hospital
        • Contact:
          • Henriette Vendelbo Graversen, MD
          • Numéro de téléphone: +45 51 49 25 95
          • E-mail: henrgv@rm.dk

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Opel label
All participants will be included in this study arm
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Safety and tolerability
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Virologic response
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
HBV markers
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Aarhus University Hospital

Collaborateurs

Charite University, Berlin, Germany

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

23 avril 2026

Achèvement primaire (Estimé)

1 avril 2028

Achèvement de l'étude (Estimé)

1 avril 2028

Dates d'inscription aux études

Première soumission

12 mai 2026

Première soumission répondant aux critères de contrôle qualité

27 mai 2026

Première publication (Réel)

28 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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