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Tests treatment safety and results for Hepatitis D, Chronic
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
ClinicalTrials.gov ID: NCT07610772
What this study is testing
What is HepB mAb19?
HepB mAb19 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatitis d, chronic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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:
You likely can't join if
- 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...
- Pregnancy or lactation
- Any vaccination 2 weeks prior to entry
- Prior receipt of HepB mAb19 therapy
See the full eligibility 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Berlin, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.