Ignite Creation Date:
2024-05-06 @ 12:09 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01505946
Status:
UNKNOWN
Last Update Posted:
2013-06-17
First Post:
2012-01-05
Brief Title:
Thrombin Generation Assay TGA as Predictive Test for Haemostatic Effectiveness of FVIII Concentrates in Haemophiliac A With Inhibitors
Sponsor:
Grifols Italia SpA
Organization:
Grifols Italia SpA
Study Overview
Official Title:
Thrombin Generation Assay TGA as Predictive Test for Haemostatic Effectiveness of Factor VIII FVIII Concentrates in Patients Affected by Inherited Haemophilia A With FVIII Inhibitors High and Low Anamnestic Response
Status:
UNKNOWN
Status Verified Date:
2013-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PredicTGA
Brief Summary:
This is an observational prospective longitudinal multicenter cohort study designed with the scope to verify whether or not TGA may predict effectiveness of different FVIII concentrates class devoid or rich of VWF in patient affected by severe or moderately severe inherited haemophilia A and inhibitors
Detailed Description:
Rationale
Hemophilia A is a serious and common hereditary bleeding disorder caused by deficiency of coagulation factor VIII FVIII Patients with this disease are treated with recombinant factor VIII or factor VIII concentrates derived from plasma
Administration of exogenous FVIII in 15-35 of cases cause the formation of antibodies to FVIII inhibitors that neutralize the activity of factor VIII making the treatment ineffectiveThe development of inhibitors of factor VIII FVIII is the most serious and challenging complication of the treatment of hemophilia A and represents the highest economic burden for a chronic disease Therefore research is making great efforts to optimize the best therapeutic approach for the disease
It has been observed that FVIII inhibitors display a wide range of immunoreactivity when tested against different classes of FVIII concentrates withwithout von Willebrand factor -VWF It has been demonstrated that the different inhibitors reactivity may correlate with different ability of inhibitors to impair thrombin generation as tested by Thrombin Generation Assay TGA In these patients TGA assay might be a tool to predict which FVIII concentrate has the greater haemostatic effectiveness
It is also uncertain if the different classes of FVIII used in ITI protocols may have a different effectiveness in reducing the occurrence of BT bleedings and if this may correlate to lower reactivity epitope specificity VWF content and may be predicted by TGA It would be very helpful to be able to give an evidence based diagnostic and prognostic instrument the TGA to aid physician to optimize the therapy for all inhibitors patients
Hemophilia A is a serious and common hereditary bleeding disorder caused by deficiency of coagulation factor VIII FVIII Patients with this disease are treated with recombinant factor VIII or factor VIII concentrates derived from plasma
Administration of exogenous FVIII in 15-35 of cases cause the formation of antibodies to FVIII inhibitors that neutralize the activity of factor VIII making the treatment ineffectiveThe development of inhibitors of factor VIII FVIII is the most serious and challenging complication of the treatment of hemophilia A and represents the highest economic burden for a chronic disease Therefore research is making great efforts to optimize the best therapeutic approach for the disease
It has been observed that FVIII inhibitors display a wide range of immunoreactivity when tested against different classes of FVIII concentrates withwithout von Willebrand factor -VWF It has been demonstrated that the different inhibitors reactivity may correlate with different ability of inhibitors to impair thrombin generation as tested by Thrombin Generation Assay TGA In these patients TGA assay might be a tool to predict which FVIII concentrate has the greater haemostatic effectiveness
It is also uncertain if the different classes of FVIII used in ITI protocols may have a different effectiveness in reducing the occurrence of BT bleedings and if this may correlate to lower reactivity epitope specificity VWF content and may be predicted by TGA It would be very helpful to be able to give an evidence based diagnostic and prognostic instrument the TGA to aid physician to optimize the therapy for all inhibitors patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 373 | OTHER | Italian RSO httposservazionaliagenziafarmacoit | None |