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

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)

Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection (NCT07610772) is a Phase 1 interventional studying Hepatitis D, Chronic and Hepatitis B Chronic Infection, sponsored by Aarhus University Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Hepatitis D, Chronic, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 15 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - 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. Who Should NOT Join This Trial: - 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

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.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Aarhus University Hospital

Aarhus, Denmark

Charité - Universitätsmedizin Berlin

Berlin, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07610772), the sponsor (Aarhus University Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07610772 clinical trial studying?

Who can participate in NCT07610772?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07610772?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07610772. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07610772. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.