The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial

Phase 3

Terminated

• Conditions: Hemophilia a; Hemophilia B; Hemophilia a with Inhibitor; Hemophilia B with Inhibitor
• Interventions: Drug: SerpinPC

• Registration Number: NCT06568302
• Lead Sponsor: ApcinteX Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-11
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-23
• Primary Completion: 2025-01-29
• Study Completion: 2025-01-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SerpinPC	SerpinPC	Participants will receive SerpinPC 1.2 milligrams/kilograms (mg/kg) subcutaneous injection every 2 weeks (Q2W) once they have completed treatment in a SerpinPC parent study.

Primary Outcome Measures

Name	Time	Method
Treated bleeds, expressed as annualized bleeding rate (ABR)	Month 0 to Month 25 or Early termination

Secondary Outcome Measures

Name	Time	Method
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
Treated spontaneous bleeds (expressed as ABR)	Month 0 to Month 25 or Early termination
Total coagulation factor and/or bypass product consumption	Month 0 to Month 25 or Early termination

Trial Locations

Locations (2)

ARENSIA Exploratory Medicine LLC; 🇬🇪 Tbilisi, Georgia

Institute of Oncology, ARENSIA Exploratory Medicine; 🇲🇩 Chisinau, Moldova, Republic of