Status:
TERMINATED
The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial
Lead Sponsor:
ApcinteX Ltd
Collaborating Sponsors:
Centessa Pharmaceuticals plc
Conditions:
Hemophilia a
Hemophilia B
Eligibility:
MALE
12-65 years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06568302
Start Date
July 11 2024
End Date
January 29 2025
Last Update
February 10 2025
Active Locations (2)
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1
ARENSIA Exploratory Medicine LLC
Tbilisi, Georgia, 0112
2
Institute of Oncology, ARENSIA Exploratory Medicine
Chisinau, Moldova, MD-2025