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

NCT ID: NCT06568302

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-11
• Study Completion Date: 2025-01-29

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

Conditions

Hemophilia a; Hemophilia B; Hemophilia a with Inhibitor; Hemophilia B with Inhibitor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SerpinPC

Intervention Type: DRUG

Administered as SC injection.

Interventions

SerpinPC

Administered as SC injection.

Intervention Type: DRUG

Other Intervention Names

Activated Protein C (APC) inhibitor

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centessa Pharmaceuticals plc

INDUSTRY

Sponsor Role: collaborator

ApcinteX Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ARENSIA Exploratory Medicine LLC

Tbilisi, , Georgia

Institute of Oncology, ARENSIA Exploratory Medicine

Chisinau, , Moldova

Countries

Georgia; Moldova

Other Identifiers

2023-509965-19

Identifier Type: OTHER

Identifier Source: secondary_id

AP-0106

Identifier Type: -

Identifier Source: org_study_id