Conditioned Pain Modulation in Patients With Hemophilia

Study Identifier:
He-Modulation
ClinicalTrials.gov Identifier:
NCT06267209
EudraCT Identifier:
N/A
Recruiting

Study Details

Medical Condition
  • Hemophilia
Study Drug
    Date
    May 2024 - Jun 2024
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Male
    Age: 20 - 65 Years years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Patients diagnosed with hemophilia A or B.
    • Patients over 18 years of age.
    • Persons with a medical diagnosis of bilateral hemophilic ankle arthropathy.
    • Patients with clinical assessment by Hemophilia Joint Health Score (\>4 points).
    • Persons with hemophilia on prophylactic treatment with FVIII / FIX coagulation concentrates or monoclonal antibodies.
    • Have signed the informed consent document.
    Exclusion Criteria
    • Patients with neurological or cognitive alterations that prevent the comprehension of the questionnaires and physical tests.
    • Patients who have had an ankle hemarthrosis in the 6 months prior to the start of the study.
    • Patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior to the study.
    • Patients who are undergoing an intervention (physiotherapeutic or orthopedic) at the time of the study.

    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
    University of Oviedo
    Oviedo, Principality of Asturias, Spain, 33006
    Status
    Recruiting