The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsor… (NCT06568302) | Clinical Trial Compass
TerminatedPhase 3
The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
Stopped: Study terminated due to business and strategic decision.
Georgia, Moldova15 participantsStarted 2024-07-11
Plain-language summary
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia
Who can participate
Age range12 Years – 65 Years
SexMALE
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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
What they're measuring
1
Treated bleeds, expressed as annualized bleeding rate (ABR)
Timeframe: Month 0 to Month 25 or Early termination