Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody (The SAMBA Study) (NCT06668727) | Clinical Trial Compass
RecruitingPhase 1
Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody (The SAMBA Study)
Denmark30 participantsStarted 2024-08-26
Plain-language summary
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. While antiviral therapies are available and suppress viral levels, treatment is long-term, does not clear the infection and rarely leads to long-term control once discontinued. Moreover, treatment access is not ideal on a global level with less than 10% of people in need receiving treatment. Although a strategy that eliminates all viral particles from the body represents the "holy grail" of HBV therapy, a strategy that leads to HBsAg loss and allows patients to stop treatment is highly desirable. New strategies to achieve either complete viral clearance or a state of viral control without the need for long-term treatment are being developed, including approaches to restore immune responses. Antibodies are key modulators of immune responses because of their dual functionality. In addition to directly targeting a viral antigen, antibodies differ from direct antivirals in that they can recruit other immune cells to eliminate infected cells and accelerate viral clearance.
This study will evaluate the safety and pharmacokinetics of a monoclonal antibody that was isolated from an HBV-vaccinated individual, HepB mAb19, as well as its potential effects on viral levels and antiviral immune responses in individuals living with CHB.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negative serum or urine pregnancy test at screening and on day 0 (study entry).
* 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 for the second method of contraception. Contraception must be used from 10 days prior to study entry and during study follow up. Acceptable methods of contraception include:
* 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 azoospermi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability
Timeframe: From enrollment to the end of follow up at 48 weeks
2
Pharmacokinetic profile
Timeframe: From enrollment to the end of follow up at 48 weeks
3
Pharmacokinetic profile
Timeframe: From enrollment to follow up at 48 weeks
4
Pharmacokinetic profile
Timeframe: From enrollment to follow up at 48 weeks
5
Pharmacokinetic profile
Timeframe: From enrollment to follow up at 48 weeks
6
Pharmacokinetic profile
Timeframe: From enrollment to follow up at 48 weeks
7
Pharmacokinetic profile
Timeframe: From enrollment to follow up at 48 weeks