Brief Title
PK Driven Prophylaxis for Hemophilia A
Official Title
Interest of Preventive Personalized Treatment in Hemophilia A
Brief Summary
The purpose of this study is to evaluate the implementation of pharmacokinetic (PK) driven prophylaxis in current clinical practice
Detailed 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
Study Type
Interventional
Primary Outcome
Joint Annual Bleeding Rate
Secondary Outcome
Total annual bleeding rate
Condition
Hemophilia A
Intervention
MyPKFiT
Study Arms / Comparison Groups
MyPKFiT
Description: Personalized prophylaxis : Treatment is adjustment according to PK modeling
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
12
Start Date
November 25, 2015
Completion Date
May 12, 2016
Primary Completion Date
May 12, 2016
Eligibility Criteria
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
Gender
Male
Ages
6 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Thierry LAMBERT, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02634424
Organization ID
P140701
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Baxter Healthcare Corporation
Study Sponsor
Thierry LAMBERT, MD, Principal Investigator, AP-HP, Bicêtre Hospital
Verification Date
August 2016