Hepatitis D, ChronicPhase 1NCT07610772
Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a Phase 1b, Open-label Trial in Individuals With Chronic Hepatitis D Infection
A Phase 1 study testing HepB mAb19 in people with Hepatitis D, Chronic and Hepatitis B Chronic Infection, run by Aarhus University Hospital at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis D, Chronic, Hepatitis B Chronic Infection
- What is being tested?
- HepB mAb19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Apr 2026to 1 Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8000
Henriette Vendelbo Graversen, MD, +45 51 49 25 95, henrgv@rm.dk
Germany1 site, 1 recruiting
- Not yet recruiting
Charité - Universitätsmedizin Berlin
Berlin
Christian Gaebler, Professor, xxxxxxxx, christian.gaebler@charite.de
About this study
Official title: 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.
Read more
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.
- Being tested
- HepB mAb19
- Keywords
- SAMBA-D, 2025-522125-36-00 (EU CT no.)
- Medical subject headings
- Hepatitis D, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepB mAb19Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Opel label | Experimental | All participants will be included in this study arm Receives: Drug: HepB mAb19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Rate and severity of solicited adverse events that are Grade 2 or above
Measured: Two weeks after each administration
Safety and tolerability
Rate and severity of treatment-emerging unsolicited adverse events (including confirmed laboratory abnormalities) 2, 12, 28 and 60 weeks after first HepB mAb19 administration.
Measured: 2, 12, 28 and 60 weeks after first HepB mAb19 administration
Safety and tolerability
Rate and severity of serious adverse events (SAEs) throughout the study period following investigational product (IP) administration
Measured: From enrollment to end of follow-up at week 60
Safety and tolerability
Rate and severity of adverse events of special interest, such as immune complex disease (ICD) throughout the study period following IP administration.
Measured: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
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.
Measured: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Assesment of HepB mAb19 elimination half-life (t1/2)
Measured: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Assesment of clearance (CL/F) of HepB mAb19
Measured: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Calculation of volume of distribution (Vz/F)
Measured: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Calculation of area under the curve (AUC) for HepB mAb19
Measured: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Calculation of HepB mAb19 decay curve
Measured: From enrollment to end of follow-up at week 60
Secondary outcomes (3)
Virologic response
Virologic response defined as HDV RNA decrease of ≥2 log10 IU/mL or to undetectable from baseline (day 0) to week 28.
Measured: From baseline (day 0) to week 28
Anti-drug antibodies
Rate of induced anti-HepB mAb19 antibodies.
Measured: From enrollment to end of follow-up at week 60
Changes in liver function tests
Changes in liver function tests (e.g. ALT, AST, alkaline phosphatase, bilirubin, albumin) at selected follow-up visits.
Measured: From enrollment to end of follow-up at week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start23 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis D, ChronicStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Ole Schmeltz Søgaard, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610772
- Sponsor's protocol ID
- SAMBA-D-001
- Other IDs
- 2025-522125-36-00, 2025
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07610772
- Acronym / sponsor ID
- SAMBA-D-001
- Keywords
- SAMBA-D, 2025-522125-36-00 (EU CT no.)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opel label | Experimental | Drug: HepB mAb19All participants will be included in this study arm |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepB mAb19All 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. | Drug | Opel label |
Primary outcome
Safety and tolerability
Time frame: Two weeks after each administration
Rate and severity of solicited adverse events that are Grade 2 or above
Safety and tolerability
Time frame: 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.
Safety and tolerability
Time frame: 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
Safety and tolerability
Time frame: 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.
Pharmacokinetic profile
Time frame: 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.
Pharmacokinetic profile
Time frame: From enrollment to end of follow-up at week 60
Assesment of HepB mAb19 elimination half-life (t1/2)
Pharmacokinetic profile
Time frame: From enrollment to end of follow-up at week 60
Assesment of clearance (CL/F) of HepB mAb19
Pharmacokinetic profile
Time frame: From enrollment to end of follow-up at week 60
Calculation of volume of distribution (Vz/F)
Pharmacokinetic profile
Time frame: From enrollment to end of follow-up at week 60
Calculation of area under the curve (AUC) for HepB mAb19
Pharmacokinetic profile
Time frame: From enrollment to end of follow-up at week 60
Calculation of HepB mAb19 decay curve
3 secondary outcomes
Virologic response
Time frame: From baseline (day 0) to week 28
Anti-drug antibodies
Time frame: From enrollment to end of follow-up at week 60
Changes in liver function tests
Time frame: From enrollment to end of follow-up at week 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HepB mAb19 in people with Hepatitis D, Chronic and Hepatitis B Chronic Infection, run by Aarhus University Hospital at 2 sites in 2 countries.
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 6 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ole Schmeltz Søgaard, MD, PhD, professor (+45 24 77 79 95, olesoega@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: Two weeks after each administration). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2026.