Individually Tailored Prophylaxis in Patients With Severe Hemophilia A (OPTIPHASE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00995046|
Recruitment Status : Terminated
First Posted : October 14, 2009
Last Update Posted : May 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hemophilia A||Drug: FVIII||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimizing Prophylaxis in Patients With Severe Haemophilia A by Tailoring the Infusions to Individual Patients' Needs Using the Calibrated Automated Thrombin Generation Test|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2012|
Active Comparator: usual prophylaxis regimen
All patients will receive their usual prophylaxis regimen during the first 6 months
6 months of prophylaxis treatment administered 3 or 4 times weekly according to patient's initial regimen, (standardized Malmö protocol 25 - 40 IU/kg/infusion). Medical visits will occur at 3-month intervals (+ 5 days) until the end of the study. Weekly, telephone calls to the patients (parents) will also be done.
Experimental: individually tailored prophylaxis regimen
All patients will receive an individually tailored prophylaxis regimen in accordance with TGT results during the second 6 month-period.
1 month period where thrombin generating capacity will be evaluated, followed by 6 months of "individually" tailored prophylaxis regimen according to TGT results. Medical visits will occur at 3-month intervals (+ 5 days) until the end of the study. Weekly, telephone calls to the patients (parents) will also be done.
- Consumption of clotting factor concentrate [ Time Frame: 13 months ]
- Number of spontaneous bleeds [ Time Frame: 13 months ]
- Number of spontaneous joint bleeds [ Time Frame: 13 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995046
|Hopital Edouard Herriot|
|Lyon, France, 69437|
|Principal Investigator:||Yesim Dargaud, MD, PhD||Hospices Civils de Lyon - France|