A Phase 1 interventional study of HepB mAb19 in Hepatitis D, Chronic and Hepatitis B Chronic Infection, sponsored by Aarhus University Hospital. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Aarhus University Hospital · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
Laboratory abnormalities in the parameters listed below:
Current, or history of:
All participants will be included in this study arm
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.
Safety and tolerability
Rate and severity of solicited adverse events that are Grade 2 or above
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Assesment of HepB mAb19 elimination half-life (t1/2)
Time frame: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Assesment of clearance (CL/F) of HepB mAb19
Time frame: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Calculation of volume of distribution (Vz/F)
Time frame: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Calculation of area under the curve (AUC) for HepB mAb19
Time frame: From enrollment to end of follow-up at week 60
Pharmacokinetic profile
Calculation of HepB mAb19 decay curve
Time frame: From enrollment to end of follow-up at week 60
Virologic response
Virologic response defined as HDV RNA decrease of ≥2 log10 IU/mL or to undetectable from baseline (day 0) to week 28.
Time frame: From baseline (day 0) to week 28
Anti-drug antibodies
Rate of induced anti-HepB mAb19 antibodies.
Time frame: 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.
Time frame: From enrollment to end of follow-up at week 60
HBV markers
* 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.
Time frame: From enrollment to end of follow-up at week 60
HDV markers
\- Anti-HDV at baseline and at selected follow-up visits.
Time frame: From enrollment to end of follow-up at week 60
Innate immune response
Changes in innate immune responses following HepB mAb19 administration.
Time frame: From enrollment to end of study at week 60
Changes in inflammatory markers
Changes in inflammatory markers following HepB mAb19 administration.
Time frame: From enrollment to end of follow-up at week 60
Changes in fibrosis grade
Changes in fibrosis grade by FibroScan from entry to end of study.
Time frame: From enrollment to end of follow-up at week 60.
Plan to share: Undecided
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Aarhus University Hospital