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Tests treatment safety and results for Hepatitis B
Official title Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody (The SAMBA Study)
ClinicalTrials.gov ID: NCT06668727
What this study is testing
What is HepB mAb19?
HepB mAb19 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for hepatitis b.
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 B virus (HBV) remains a major global health problem with an estimated 257 million people living with the infection worldwide. Chronic HBV (CHB) is a major cause of liver cirrhosis and hepatocellular carcinoma.
- 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 49 days prior to 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 12 months prior to entry or done at pre-infusion visit, if prior results not available.
- Alpha fetoprotein \>20 ng/ml. Note: Alpha-fetoprotein (AFP) above normal but \< 20 is acceptable for entry if earlier AFP levels (older than 6...
- HIV-1, HCV or hepatitis delta virus infection 12 months prior to 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 49 days prior to study entry (day 0):
- HBV DNA below lower limit of quantification;
- HBs antibody negative;
- HBeAg 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, one of which must be from the highly effective methods for contraception listed below. Barrier methods of contraception are permitted...
- Contraceptive subdermal implant;
- Intrauterine device or intrauterine system;
- Combined estrogen and progestogen oral contraceptive;
- Injectable progestogen;
- Contraceptive vaginal ring;
- Percutaneous contraceptive patches;
- 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) 12 months prior to entry or done at the pre-infusion visit. Note...
- Presence of a LI-RADS4 or 5 liver lesion on imaging 12 months prior to entry or done at pre-infusion visit, if prior results not available.
- Alpha fetoprotein \>20 ng/ml. Note: Alpha-fetoprotein (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 12 months prior to 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 Electrocardiogram (ECG) abnormalities based on the average of the triplicate ECG recordings (e.g., PR interval \>210 ms, QT corrected for heart rate using the Fridericia's...
- History of systemic corticosteroids, immunosuppressive anti-cancer, systemic interferons or interleukins 6 months prior to entry;
- History of chronic liver disease from another cause, ICD, 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 2 weeks prior to entry.
- Laboratory abnormalities in the parameters listed below:
- Absolute neutrophil count \<1,000 /mm3
- Hemoglobin \<10 gm/dL (6.21 mmol/L)
- Platelet count \<150,000 /mm3
- ALT \>2.0 x Upper normal limit (ULN)
- AST \>2.0 x ULN
- Total bilirubin \>1.5 ULN (except individuals with known Gilbert\'s)
- Albumin \<3.5 gm/dL
- Estimated glomerular filtration rate (eGFR) \<70 mL/min
- INR ≥1.2
- Pregnancy or lactation;
- Any vaccination 2 weeks prior to entry;
- 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 12 weeks prior to, or expected participation during this study
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Denmark
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 Aarhus N, Denmark. 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.