PK Driven Prophylaxis for Hemophilia A (OBTC)

Assistance Publique - Hôpitaux de Paris

Status: Terminated

Conditions: Hemophilia A

Treatments: Device: MyPKFiT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02634424

P140701

Details and patient eligibility

About

The purpose of this study is to evaluate the implementation of pharmacokinetic (PK) driven prophylaxis in current clinical practice

Full description

Starting from 3 pharmacokinetic (PK) points, data are entered in the PK calculator device, and treatment dose is adjusted following the results of PK values obtained and clinical bleeding data

Enrollment: 12 patients

Sex: Male

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male Patient
• Severe or moderately severe haemophilia A (FVIII = 2 %), preventively treated (processing) by ADVATE for at least 6 months,
• At last 6 years old,
• An informed consent must be signed by the patient or his legal representative for the patients minor.
• Affiliated to a national insurance scheme

Exclusion criteria

• Previous or actual treatment with FVIII inhibitors > 0,6 UB at the selection
• Induction of immune tolerance
• Planned orthopedic surgery for the 18 next months
• Any other haemostatic pathology
• Any treatment interacting on the haemostasis
• Patient under guardianship
• Patient participating in another biomedical research

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

MyPKFiT

Experimental group

Description:

Personalized prophylaxis : Treatment is adjustment according to PK modeling

Treatment:

Device: MyPKFiT