Status:
COMPLETED
A Proof-of-concept Study to Reduce Treatment Burden in Haemophilia Participants Receiving Factor VIII and Factor IX Infusions
Lead Sponsor:
Takeda
Conditions:
Hemophilia
Eligibility:
MALE
6+ years
Phase:
NA
Brief Summary
The main aim is to describe how the treatment burden and challenges of participants, relatives, and doctors during regular Factor VIII and Factor IX infusions to treat hemophilia evolve using a virtua...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male participant over the age of 6 years, with diagnosed Congenital Hemophilia A or B, whatever the severity is
- Participant under long-term prophylaxis with intravenous Factor VIII or Factor IX infusions
- Participant (or the legal guardians if participant age \<18 years) able and willing to give written informed consent and to comply with the requirements of the study protocol
- Participant affiliated to the national social security or beneficiary to such insurance
- Exclusion criteria:
- Participant with known or suspected hypersensitivity to virtual-reality based tools
- Participant with central venous line for the administration of Factor VIII or Factor IX
- Participant (and the legal guardians if participant age \<18 years) with history of unreliability or non-cooperation (including for completion of self-reported questionnaires)
- Participant (and the legal guardians if participant age \<18 years) with insufficient comprehension of French language
- Participant taking part in another clinical trial
- Participant deprived of his liberty by judicial or administrative order
- NB: participants with haemophilia A having participated in the test phase of the study could be included in the clinical study itself after a period of 4 months minimum with no use of the virtual-reality based solution.
Exclusion
Key Trial Info
Start Date :
June 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05437211
Start Date
June 23 2023
End Date
February 21 2024
Last Update
June 5 2025
Active Locations (6)
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1
Centre de Reference Hemophilie Unite D'Hemostase Clinique
Bron, Auvergne-Rhône-Alpes, France, 69677
2
CHU Estaing
Clermont-Ferrand, Auvergne-Rhône-Alpes, France, 69003
3
Hôpital de Hautepierre - Pôle MIRMED
Strasbourg, Grand Est, France, 7200
4
CHU Purpan
Toulouse, Haute-Garonne, France, 31059