The Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial (PRESent-6)

ApcinteX

Status and phase

Terminated

Phase 3

Conditions

Hemophilia B with Inhibitor

Hemophilia B

Hemophilia a

Hemophilia a with Inhibitor

Treatments

Drug: SerpinPC

Study type

Interventional

Funder types

Industry

Identifiers

NCT06568302

AP-0106

2023-509965-19 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with hemophilia

Enrollment

15 patients

Sex

Male

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

15 participants in 1 patient group

SerpinPC

Experimental group

Description:

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.

Treatment:

Drug: SerpinPC