Monoclonal Hepatitis B antibody safety and antiviral activity in chronic hepatitis D

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1b, open-label study designed to assess the safety and antiviral activity of HepB mAb19 in individuals with chronic hepatitis D infection. Fifteen participants with confirmed HDV infection will receive the HepB mAb19 antibody, which targets hepatitis B surface antigens, to see if it lowers circulating HBV antigens and impacts HDV-related disease activity. The trial includes adults who meet eligibility criteria and excludes those with advanced liver failure or significant antibody/vaccine reactions. Primary goals focus on safety and tolerability, with secondary observations on antiviral activity markers. Conducted at Aarhus University Hospital and Charité in Berlin, the study emphasizes careful monitoring and informed consent throughout the treatment period.

Why it matters

Who can join: the full rules

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

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Charité - Universitätsmedizin Berlin
  Berlin, Germany Not yet recruiting

Study contacts

• Study coordinator: Ole Schmeltz Søgaard, MD, PhD, professor
• Email: olesoega@rm.dk
• Phone: +45 24 77 79 95

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.