A Proof-of-concept Study to Reduce Treatment Burden in Haemophilia Participants Receiving Factor VIII and Factor IX Infusions

Takeda

Status: Completed

Conditions: Hemophilia

Treatments: Device: Virtual-reality (VR) Based Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05437211

TAK-660-4013

MACS-2020-120101 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male participant over the age of 6 years, with diagnosed Congenital Hemophilia A or B, whatever the severity is
2. Participant under long-term prophylaxis with intravenous Factor VIII or Factor IX infusions
3. 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
4. Participant affiliated to the national social security or beneficiary to such insurance

Exclusion criteria

1. Participant with known or suspected hypersensitivity to virtual-reality based tools
2. Participant with central venous line for the administration of Factor VIII or Factor IX
3. Participant (and the legal guardians if participant age <18 years) with history of unreliability or non-cooperation (including for completion of self-reported questionnaires)
4. Participant (and the legal guardians if participant age <18 years) with insufficient comprehension of French language
5. Participant taking part in another clinical trial
6. 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

VR-based Experimental Group

Experimental group

Description:

Participants will receive Factor VIII or Factor IX infusion using a VR-based solution. The VR-based solution will be provided in a medical device CE marked and specifically developed by Deepsen, a French company specializing in e-health solutions to reduce pain. It includes both a mobile phone application (for an explanation on infusions) and a 3D mask to be used during infusions.

Treatment:

Device: Virtual-reality (VR) Based Solution