Central Pain Mechanisms and Clinical and Psychological Factors Associated With Pain Interference in Daily Life in Adults With Hemophilia and Hemophilic Arthropathy

Study Identifier:
HE-DOLIFE
ClinicalTrials.gov Identifier:
NCT07516730
EudraCT Identifier:
N/A
Will Be Recruiting

Study Details

Medical Condition
  • Hemophilia
Study Drug
    Date
    Apr 2026 - Jun 2026
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Male
    Age: 35+ years years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Diagnosis of hemophilia A or B
    • Age equal to or greater than 35 years
    • Clinical diagnosis of hemophilic arthropathy in at least one lower limb joint
    • Clinically relevant joint involvement, defined as a total score on the Hemophilia Joint Health Score (HJHS) greater than 4 points
    • Stable prophylactic treatment with FVIII/FIX concentrates or monoclonal antibodies
    • Provision of written informed consent
    Exclusion Criteria
    • Presence of neurological or cognitive impairments that prevent understanding of the questionnaires or performance of the study tests
    • Episode of hemarthrosis in the lower limbs within the 3 months prior to assessment
    • Use of analgesics, nonsteroidal anti-inflammatory drugs, opioids, or other medications with potential effects on pain perception or modulation within the 72 hours prior to assessment
    • Receiving, at the time of the study, physiotherapy, infiltrative, or orthotic interventions aimed at pain or function of joints affected by hemophilic arthropathy

    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

    No locations found.