EVALUATION of the OVERALL HAEMOSTATIC CAPACITY of MIM8 with GLOBAL HAEMOSTASIS ASSAYS and FIBRIN CLOT ULTRASTRUCTURE

Launched by HOSPICES CIVILS DE LYON · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Mim8 for men with severe hemophilia A, a condition where the blood doesn't clot properly due to a lack of a protein called Factor VIII. Hemophilia A can lead to spontaneous bleeding, and some patients develop inhibitors that make traditional treatments less effective. Mim8 is designed to help these patients by mimicking the function of Factor VIII, potentially improving their ability to stop bleeding. The trial aims to evaluate how well Mim8 works in different situations by looking at blood samples and measuring the body’s clotting ability.

To participate in the trial, men over the age of 18 must have severe hemophilia A and should not be receiving a treatment called emicizumab. Participants will need to provide some additional blood samples for testing, but they should not have any other bleeding disorders or have received other clotting agents recently. Throughout the trial, participants will undergo various assessments to monitor how Mim8 affects their blood clotting. This study could help improve treatment options for men with hemophilia A, especially those who struggle with current therapies.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male patients,
• • Age \> 18 years at time of inclusion
• • Diagnosis of severe hemophilia A (FVIII \<2%)
• • Severe hemophilia A (FVIII \<2%) and not receiving emicizumab prophylaxis
• • Obtaining the patient's non-opposition
• • Ability to comply with the study protocol, in the investigator's judgment
• Exclusion Criteria:
• • Not willing to provide extra blood for the experiments
• • Patients carrying the diagnoses of other coagulopathies in addition to hemophilia A
• • Patients that have received any hemostatic agent within 5 half-lives of the blood draw.