A Clinical Study to Assess the Safety and Efficacy of Sutacimig in Participants With Congenital Factor VII Deficiency
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
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• 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.
Locations
Other Locations
United Kingdom
Royal London Hospital
RECRUITING
London
Contact Information
Primary
Hemab Aps
clinicaltrials@hemab.com
+44 (0) 808 304 6409
Time Frame
Start Date: 2026-01
Estimated Completion Date: 2026-07
Participants
Target number of participants: 18
Treatments
Experimental: Participants with a FVII(a) level of < 10%
Experimental: Participants with a FVII(a) level of ≥10%
Related Therapeutic Areas
Sponsors
Leads: Hemab ApS