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New treatment option for Hepatitis b Virus
Official title HepB mAb19 in Individuals With Chronic Hepatitis B Infection
ClinicalTrials.gov ID: NCT05856890
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 b virus.
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
- This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B (CHB) on nucleos(t)ide analog therapy (NRTI).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
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
- Age 18 to 70;
- HBV infection confirmed by positive HBsAg for \>/= 6 months;
- On HBV-active nucleos(t)ide therapy for \>/= 6 months without change in NRTI in the previous 3 months;
- The following laboratory values within 49 days from study entry (day 0):
- HBV DNA below lower limit of quantification;
You likely can't join if
- \- Clinical symptoms, imaging studies or liver histology suggestive of advanced fibrosis (exclude fibrosis grade 3 and 4 by FibroScan (Fibroscan®\< 9...
- Presence of a LI-RADS4 or 5 liver lesion on imaging within 12 months from entry or done at pre-infusion visit, if prior results not available.
- Alpha fetoprotein \> 20 ng/ml Note: AFP above normal but \< 20 is acceptable for entry if earlier AFP levels (older than 6 months) are within normal...
- HIV-1, HCV or hepatitis delta virus infection within 12 months from entry or done at screen, if prior results not available.
- History of hematopoietic stem cell transplant or solid organ transplant;
- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, monoclonal antibody or vaccine, or multiple drug allergies...
See the full eligibility criteria
- Age 18 to 70;
- HBV infection confirmed by positive HBsAg for \>/= 6 months;
- On HBV-active nucleos(t)ide therapy for \>/= 6 months without change in NRTI in the previous 3 months;
- The following laboratory values within 49 days from study entry (day 0):
- HBV DNA below lower limit of quantification;
- HBsAg \> 10 IU/mL;
- HBs antibody negative;
- Ability and willingness to provide informed consent;
- For participants who can become pregnant (i.e., participants who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical...
- Participants who can become pregnant must agree to use two methods of contraception.
- Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this partner is the sole partner for that participant. The documentation of partner sterility can come from...
- Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to study entry and during study follow up to avoid impregnating...
- \- Clinical symptoms, imaging studies or liver histology suggestive of advanced fibrosis (exclude fibrosis grade 3 and 4 by FibroScan (Fibroscan®\< 9 kpa) within 12 months from entry or done at the pre-infusion visit...
- Presence of a LI-RADS4 or 5 liver lesion on imaging within 12 months from entry or done at pre-infusion visit, if prior results not available.
- Alpha fetoprotein \> 20 ng/ml Note: AFP above normal but \< 20 is acceptable for entry if earlier AFP levels (older than 6 months) are within normal range and imaging is negative in last 3 months).
- HIV-1, HCV or hepatitis delta virus infection within 12 months from entry or done at screen, if prior results not available.
- History of hematopoietic stem cell transplant or solid organ transplant;
- Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, monoclonal antibody or vaccine, or multiple drug allergies (non-active hay fever is acceptable);
- History of cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death);
- History or presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., QT corrected for heart rate using the Fridericia's correction factor [QTcF] \> 450 ms for...
- History of systemic corticosteroids, immunosuppressive anti-cancer, systemic interferons or interleukins within the last 6 months;
- History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation.
- Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness within 2 weeks prior to Day 0.
- Laboratory abnormalities in the parameters listed below:
- Absolute neutrophil count \< 1,000 /mm3
- Hemoglobin \< 10 gm/dL
- Platelet count \< 150,000 /mm3
- ALT \> 2.0 x ULN
- AST \> 2.0 x ULN
- Total bilirubin \> 1.5 ULN (except individuals with known Gilbert's)
- Albumin \< 3.5 gm/dL
- Calculated creatinine clearance \< 70 mL/min (using the Cockcroft Gault formula).
- INR \>/= 1.2
- Pregnancy or lactation;
- Any vaccination within 14 days prior to IP administration;
- Receipt of anti-HBV mAb therapy of any kind in the past (including HBIG);
- Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 New York, New York, United States. 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.