Trials / Unknown
UnknownNCT02781766
TGA (Thrombin Generation Assay) and Prophylaxis in Haemophilia
Thrombin Generation Capacity of Patients With Severe Haemophilia Receiving Prophylaxis
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Hospices Civils de Lyon · Academic / Other
- Sex
- Male
- Age
- 2 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
Haemophilic arthropathy is one of the major complications of severe haemophilia. In order to maintain plasma clotting factor activity levels above 1% and avoid spontaneous joint bleeds and other serious bleeding events, prophylactic factor replacement therapy is used. Because of the high cost and limited availability of clotting factor concentrates, dosing is a crucial issue for prophylaxis therapy. Several studies reported a better correlation between clinical bleeding tendency of patients with haemophilia and thrombin generation assay results compared to FVIII/FIX levels. However there is no specific data showing that thrombin generation may be a better indicator of the clinical efficacy of prophylaxis compared to the conventional FVIII measurement. The main objective of this open, multicentre, prospective study is to compare trough thrombin generation capacity and FVIII levels in severe haemophilia patients and compare these two laboratory results with: * the number of spontaneous haemarthroses and other spontaneous serious bleeds occurred in the last 6 months * the number of additional FVIII units used in the last 6 months This project requires no change in term of type of treatment : During the study, each patient will be treated by his usual clotting factor at the usual regimen (frequency and dosage). The clinical outcome with the usual prophylaxis regimen will be correlated to TGA results
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Thrombin generation measurement. |
Timeline
- Start date
- 2016-08-08
- Primary completion
- 2019-09-08
- Completion
- 2019-09-08
- First posted
- 2016-05-24
- Last updated
- 2019-07-10
Locations
7 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02781766. Inclusion in this directory is not an endorsement.