A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency
ConditionCongenital Factor VII Deficiency
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHemab ApS
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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%.
Trial design
Treatments tested in this trial
- Sutacimig
- Sutacimig
Treatment groups
18 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov