NCT05437211Completed
A Proof-of-concept Study to Reduce Treatment Burden in Haemophilia Participants Receiving Factor VIII and Factor IX Infusions
Ability of a Virtual-reality Based Solution Aiming to Reduce Patient Burden Related to Repetitive Intravenous Perfusions. A Proof-of-concept Study in Hemophilia Patients Receiving Prophylactic Factor VIII or Factor IX Infusions
Source: ClinicalTrials.gov · Last updated 5 Jun 2025
Brief summary (registry, in English)
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 virtual-reality (VR) based solution. The study also aims to find out how well the VR based solution is tolerated and how satisfied the participants, relatives, and doctors are with it. The VR-based solution includes a mobile phone app and a 3D mask. Participants will use the VR-based solution while receiving prophylactic Factor VIII and Factor IX infusions for 4 weeks at home. Participants will visit the clinic for the last infusion; at this time data will be collected from participants, relatives, and doctors
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 24 Jun 2022
- Start date
- 23 Jun 2023
- Primary completion date
- 21 Feb 2024
- Lead sponsor
- Takeda
- Diseases
- Haemophilia
- NCT number
- NCT05437211
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 23 Jun 2023 to the primary completion date, 21 Feb 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participant with known or suspected hypersensitivity to virtual-reality based tools
Age
- 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
Other
- Participant with central venous line for the administration of Factor VIII or Factor IX
- 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.
Who the study is looking for
- 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
Age in the registry: 6 years to - · Sex: Male · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre de Reference Hemophilie Unite D'Hemostase Clinique Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| CHU Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Hopital Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hôpital de Hautepierre - Pôle MIRMED Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| CHU Purpan Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.