Hemophilia a, Hemophilia a with Inhibitor, Hemophilia B, Hemophilia B with Inhibitor
Conditions
Keywords
Hemophilia, SerpinPC
Brief summary
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia
Interventions
DRUGSerpinPC
Administered as SC injection.
Sponsors
Centessa Pharmaceuticals plc
ApcinteX Ltd
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male participants greater than or equal to (\>=) 12 and less than or equal to (\<=) 65 years of age at the time of informed consent * Completed participation in a sponsored SerpinPC hemophilia clinical trial and, in the opinion of the investigator, was compliant with the study including compliance with diary entries. * Capable of providing written informed consent (adolescent assent and parent/guardian consent when appropriate) for participation
Exclusion criteria
* Previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or embolic stroke * Participation in another interventional clinical trial, except for SerpinPC trials * Any other significant conditions or comorbidities that, in the opinion of the investigator, would make the subject unsuitable for enrolment or could interfere with participation in or completion of the study * Treatment with anticoagulant or antiplatelet drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treated bleeds, expressed as annualized bleeding rate (ABR) | Month 0 to Month 25 or Early termination |
Secondary
| Measure | Time frame |
|---|---|
| Treated spontaneous bleeds (expressed as ABR) | Month 0 to Month 25 or Early termination |
| Treated spontaneous joint bleeds (expressed as ABR) | Month 0 to Month 25 or Early termination |
| All bleeds requiring treatment (expressed as ABR, ie, all treated bleeds and all bleeds that would ordinarily be treated with factor concentrate/bypass agent if therapy were available) | Month 0 to Month 25 or Early termination |
| Total coagulation factor and/or bypass product consumption | Month 0 to Month 25 or Early termination |
Countries
Georgia, Moldova
Outcome results
None listed