A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency
Recruiting
Phase 2
Interventional Study
Congenital Factor VII Deficiency
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 18 (estimated)
- Sponsor
- Hemab ApS · Industry
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 18 to 60 years, inclusive, at the time of signing informed consent.
2. Diagnosis of FVIID defined by Factor VII:C activity \< 10% documented on ≥ 2 different laboratory measurements by local laboratory assessment.
3. Severe bleeding history characterized by history of a m…
Contacts