Resistance Training With Blood Flow Restriction in Hemophilia

Study Identifier:
Hemo-BFR-22-24
ClinicalTrials.gov Identifier:
NCT05568524
EudraCT Identifier:
N/A
Unmapped

Study Details

Medical Condition
  • Hemophilia
Study Drug
    Date
    Jan 2024 - Nov 2025
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Male
    Age: 18 - 60 Years years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • diagnosis of hemophilia A or B and undergoing prophylaxis;
    • willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations;
    • approval by their hematologist to participate in the exercise program;
    • age between 18 and 60 years;
    • informed consent signed.
    Exclusion Criteria
    • the inability to attend exercise sessions at least twice a week for 8 consecutive weeks;
    • non adherence to instruction on proper exercise technique;
    • surgical procedures performed 6 weeks prior to or during the exercise program; - participation in any other form of exercise, not previously done, during the study;
    • changes in medication during the study;
    • a major bleeding episode that posed a risk or prevented exercise;
    • another hemostatic defect;
    • need for major surgery;
    • withdrawal of informed consent.

    Protocol Summary

    This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

    Trial Locations

    Location
    Status
    Location
    Facultat de Fisioteràpia
    Valencia, Valencia, Spain, 46010
    Status
    N/A