The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Administered as SC injection.
ARENSIA Exploratory Medicine LLC
Tbilisi, Georgia
Institute of Oncology, ARENSIA Exploratory Medicine
Chisinau, Moldova
Treated bleeds, expressed as annualized bleeding rate (ABR)
Time frame: Month 0 to Month 25 or Early termination
Treated spontaneous bleeds (expressed as ABR)
Time frame: Month 0 to Month 25 or Early termination
Treated spontaneous joint bleeds (expressed as ABR)
Time frame: 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)
Time frame: Month 0 to Month 25 or Early termination
Total coagulation factor and/or bypass product consumption
Time frame: Month 0 to Month 25 or Early termination
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