A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency
Recruiting now · Phase 2
Conditions studied: Congenital Factor VII Deficiency
In brief
Open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of sutacimig monotherapy in participants with congenital FVII deficiency (FVIID).
Key facts
- Study ID
- NCT07347249
- Run by
- Hemab ApS
- People needed
- 18
- Starts
- 2026-03-11
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 to 60 years, inclusive, at the time of signing informed consent.
- Diagnosis of FVIID defined by Factor VII:C activity < 10% documented on ≥ 2 different laboratory measurements by local laboratory assessment.
- Severe bleeding history characterized by history of a major bleeding event and/or receipt of recombinant activated FVII or fresh frozen plasma as treatment for bleeding or a severe clinical bleeding history as defined by the Investigator.
- Has the ability to provide informed consent to participate in the trial.
You may not qualify if…
- Presence of known inhibitors to FVII or FVIIa
- History of clinically significant hypersensitivity associated with monoclonal antibody therapies.
- History of venous or arterial thrombosis or thromboembolic disease, with the exception of catheter-associated superficial vein thrombosis.
- Known thrombophilia risk by the following criteria: Homozygous Factor V Leiden (FVL), compound heterozygous FVL/Prothrombin gene mutation, antithrombin <50%, congenital protein C, and protein S deficiency with levels <50%.
- Clinically significant comorbidity that may interfere with study participation.
- Use of concomitant therapy not permitted during the study (i.e., other platelet inhibitors, desmopressin, fibrinolysis inhibitors, except if used as local treatment [e.g., for oral bleeds])
- Female participants who are pregnant or breastfeeding.
Where it is running
- Royal London Hospital — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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