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NCT06568302TerminatedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 10 Feb 2025

Brief summary (registry, in English)

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

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
15 (actual)
First submitted
21 Aug 2024
Start date
11 Jul 2024
Primary completion date
29 Jan 2025
Lead sponsor
ApcinteX Ltd
Diseases
Haemophilia
NCT number
NCT06568302
EudraCT number
2023-509965-19

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or embolic stroke
  • Treatment with anticoagulant or antiplatelet drugs

Other illness

  • 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

Other

  • Participation in another interventional clinical trial, except for SerpinPC trials

Who the study is looking for

  • 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

Age in the registry: 12 years to 65 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
ARENSIA Exploratory Medicine LLC
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Institute of Oncology, ARENSIA Exploratory Medicine
Coordinator of this site? Confirm its status
ChisinauMoldovaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.