Actively Recruiting
A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency
Led by Hemab ApS · Updated on 2026-01-30
18
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years, inclusive, at the time of signing informed consent.
- Diagnosis of Factor VII deficiency defined by Factor VII:C activity less than 10% on at least two separate laboratory tests.
- History of severe bleeding, including major bleeding events or treatment with recombinant activated FVII or fresh frozen plasma for bleeding, or severe clinical bleeding as determined by the Investigator.
- Ability to provide informed consent to participate in the trial.
You will not qualify if you...
- Presence of known inhibitors to Factor VII or activated Factor VII.
- History of significant allergic reactions to monoclonal antibody therapies.
- History of venous or arterial thrombosis or thromboembolic disease, except catheter-associated superficial vein thrombosis.
- Known high risk of blood clots due to specific genetic or protein deficiencies (such as homozygous Factor V Leiden, compound heterozygous Factor V Leiden/Prothrombin gene mutation, antithrombin less than 50%, congenital protein C or protein S deficiency less than 50%).
- Any serious health condition that could interfere with participation in the study.
- Use of certain medications not allowed during the study, including some platelet inhibitors, desmopressin, and fibrinolysis inhibitors (except for local treatments like oral bleeds).
- Female participants who are pregnant or breastfeeding.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Royal London Hospital
London, United Kingdom, E1 2ES
Actively Recruiting
Research Team
H
Hemab Aps
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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