Status:
TERMINATED
Individually Tailored Prophylaxis in Patients With Severe Hemophilia A
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Hemophilia A
Eligibility:
MALE
6-45 years
Phase:
NA
Brief Summary
Patients with severe haemophilia A lack clotting factor FVIII and suffer from spontaneous and traumatic bleeds. In the absence of treatment, frequent bleeds in joints lead to severe joint destruction....
Eligibility Criteria
Inclusion
- Severe haemophilia A (FVIII \< 1 IU/dl)
- Currently on prophylactic therapy administered at least 3 times per week with a clinical efficiency
- Age: 6 - 45 years
- Adequate venous access in adults and children i.e. presence of 2 or more good quality peripheral veins, in order to avoid the need for a central venous device. One peripheral vein for FVIII infusions and one other for blood sampling are required.
- Competent in home treatment and infusion therapy (patient or parents)
- Ability of patient or family (for minors) to give informed consent
- Patient affiliated to French Social Insurance System.
Exclusion
- Age \< 6 years and \> 45 years
- Hemophilia A with documented history of inhibitor
- Clinically symptomatic liver disease (supported by e.g. diagnosis of cirrhosis, portal hypertension, ascites, PT \> 5 seconds above upper limit of normal)
- Platelet count \< 100x109/l
- Planned elective surgery within 13 months
- Poor venous access according inclusion criteria
- Presence of a documented target joint
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00995046
Start Date
September 1 2009
Last Update
May 14 2013
Active Locations (1)
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1
Hopital Edouard Herriot
Lyon, France, 69437