Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
12 participants
INTERVENTIONAL
2015-11-25
2016-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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MyPKFiT
Personalized prophylaxis : Treatment is adjustment according to PK modeling
MyPKFiT
Adjustment of the treatment dose using a decision support software according to the PK values
Interventions
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MyPKFiT
Adjustment of the treatment dose using a decision support software according to the PK values
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
MALE
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Thierry LAMBERT, MD
Role: PRINCIPAL_INVESTIGATOR
AP-HP, Bicêtre Hospital
Locations
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AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, , France
Countries
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Other Identifiers
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P140701
Identifier Type: -
Identifier Source: org_study_id
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