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

Description

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Hemophilia a
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado School of Medicine, Aurora, Colorado, United States, 80045-7202

Iowa City

University of Iowa Healthcare, Iowa City, Iowa, United States, 52242

Pittsburgh

Hemophilia Center of Western Pennsylvania, Pittsburgh, Pennsylvania, United States, 15213-4306

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

12 Years to 65 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

ApcinteX Ltd,

Study Record Dates

2028-11