RECRUITING

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

Conditions

Hemophilia a Hemophilia B Hemophilia a with Inhibitor Hemophilia B with Inhibitor Hemophilia SerpinPC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Global Open-label Extension Study to Observe the Long-term Safety and Efficacy of SerpinPC in Subjects with Hemophilia Who Completed a Sponsored SerpinPC Clinical Trial

Quick Facts

Study Start:2024-07-11

Study Completion:2028-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06568302

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 65 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Centessa Pharmaceuticals

CONTACT

617-468-5770

presentprogram@centessa.com

Study Locations (Sites)

University of Colorado School of Medicine

Aurora, Colorado, 80045-7202

United States

University of Iowa Healthcare

Iowa City, Iowa, 52242

United States

Hemophilia Center of Western Pennsylvania

Pittsburgh, Pennsylvania, 15213-4306

United States

Collaborators and Investigators

Sponsor: ApcinteX Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-11

Study Completion Date2028-11

Study Record Updates

Study Start Date2024-07-11

Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

Hemophilia
SerpinPC

Additional Relevant MeSH Terms

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