TGA (Thrombin Generation Assay) and Prophylaxis in Haemophilia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-08

Study Completion Date

2019-09-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thrombin Generation Assay (TGA) as Predictive Test for Haemostatic. Effectiveness of FVIII Concentrates in Haemophiliac A With Inhibitors

NCT01505946

Severe Hemophilia A With Inhibitor

UNKNOWN

Monitoring of Anti-TFPI in Hemophilia

NCT07101926

Hemophilia Rebalancing Agents Prophylaxis

RECRUITING

Does the Thrombin Generation Test Performed During the Pharmacokinetic Profile of the Substitutive Factor VIII Bring Benefits to the Personalized Treatment of Pediatric Patients and Adult Hemophilia A Patients Under Prophylaxis ?

NCT02803502

Hemophilia

UNKNOWN NA

TFPI Levels in Haemophilia A and B Patients

NCT04570696

Haemophilia A and B

UNKNOWN

Individually Tailored Prophylaxis in Patients With Severe Hemophilia A

NCT00995046

Hemophilia A

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Haemophilia A

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

One arm: patients with severe haemophilia A on prophylaxis

Patients with severe haemophilia A (FVIII \< 1 IU/dl), currently on prophylactic therapy , having the same prophylaxis regimen in the last six months, aged between 2 (with a body weight ≥12.5 kg ) and 45 years , with adequate venous access, having patient's diary or equivalent regularly completed and able to give informed consent

Group Type OTHER

Thrombin generation measurement.

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thrombin generation measurement.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Severe haemophilia A (FVIII \< 1 IU/dl)
* Currently on prophylactic therapy
* The same prophylaxis regimen in the last six months
* Age: 2 (with a body weight ≥12.5 kg ) - 45 years
* Adequate venous access
* Haemophilia patient's diary or equivalent regularly completed
* Ability of patient or family (for minors) to give informed consent
* Subject with health insurance

Exclusion Criteria

* Age \<2 and \>45 years
* Haemophilia A with documented inhibitor in the last 12 months
* Clinically symptomatic liver disease (historical evidence documented in patient's medical file)
* Platelet count \< 100x109/l
* Poor venous access
* Presence of a documented target joint
* Subject under legal protection measure.

Minimum Eligible Age

2 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.