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NCT06668727: SAMBA
Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody (The SAMBA Study)
Phase 1 trial testing HepB mAb19 in Hepatitis B in 30 participants. Currently enrolling.
26 August 2027
Quick facts
| Lead sponsor | Aarhus University Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 26 August 2024 |
| Primary completion | 26 August 2027 |
| Estimated completion | 26 August 2027 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- HepB mAb19 — full drug profile →
Conditions studied
- Hepatitis B — all drugs for Hepatitis B →
Sponsor
Aarhus University Hospital
Who can join
Adults 18 to 70, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacotherapy of Liver Fibrosis and Hepatitis: Recent Advances.
Zhao L, Tang H, Cheng Z. · · 2024 · cited 12× · PMID 39770566 · DOI 10.3390/ph17121724
Verify or expand the search:
- PubMed search for NCT06668727
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HepB mAb19
Trials testing the same drug.
- NCT05856890 — HepB mAb19 in Individuals With Chronic Hepatitis B Infection · Phase 1 · recruiting
Other recruiting trials for Hepatitis B
Currently open trials in the same condition.
- NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
- NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease · Phase 1 · recruiting
- NCT06947356 — Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads · NA · recruiting
- NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
- NCT06623071 — Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384 · recruiting
Other Aarhus University Hospital trials
Trials by the same sponsor.
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- NCT07454486 — TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cance · not yet recruiting
- NCT07284069 — Senicapoc and Perampanel for Newly Diagnosed Glioblastoma · EARLY_PHASE1 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06668727 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aarhus University Hospital
- Last refreshed: 31 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06668727.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing