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Hemophilia A clinical trials

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NCT ID: NCT02199639 Recruiting - Clinical trials for Patients With Haemophilia

Transcultural Multidisciplinary Evaluation of Patients With Hemophili

ibHEro
Start date: March 2014
Phase: N/A
Study type: Observational

Multidisciplinary evaluation of patients with hemophilia Spain, El Salvador and Bolivia. It aims to analyze and evaluate the skeletal muscle of patients affected with hemophilia Spain, El Salvador and Bolivia; describe deficit mobility and muscular strength, depending on the degree of injury, age, presence of inhibitors and the development of physical activity; identify the relationship between the functional deficit by clinical assessment performed with the use of validated measurement scales, the assessment of the degree of injury to specific scales of hemophilia; detect biomechanical alterations of the lower limbs and their impact on gait in patients with hemophilia; and evaluate the factors that influence the perception of illness and quality of life of patients with hemophilia.

NCT ID: NCT02198430 Recruiting - Haemophilia Clinical Trials

Multidisciplinary Evaluation of Patients With Hemophilia

HOLISTIC
Start date: May 2014
Phase: N/A
Study type: Observational

Multidisciplinary assessment of the physical, functional and psychosocial alterations in patients with hemophilia around the country. The aims of this study are: - Descriptive study of joint involvement in hemophilia patients with and without a history of hemarthrosis. - Descriptive study of the alterations of periarticular muscle strength as a result of acute processes or the development of chronic articular sequelae. - Descriptive study of biomechanical changes in lower limb joints and their impact on gait in patients with hemophilia. - Descriptive study of the joint space, regarding hemarthrosis and synovitis, intraarticular by ultrasonography. - Descriptive study of the relationship between skeletal muscle pathology in patients with hemophilia and their perceptions of it and their quality of life.

NCT ID: NCT02197611 Recruiting - Haemophilia Clinical Trials

Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia.

ADHAESIONE
Start date: September 2015
Phase: N/A
Study type: Observational [Patient Registry]

Research project for the development, construction and validation of a questionnaire of adherence to treatment in adult patients with hemophilia. It aims to build a scale according to five relevant dimensions of adherence to treatment: 1) physician-patient relationship, 2) knowledge of the disease, 3) previous bleeding problems, 4) knowledge of future consequences and difficulties, and 5) benefits of treatment.

NCT ID: NCT02191436 Recruiting - Haemophilia Clinical Trials

Adherence to Treatment in Hemophilia

ADHERENCE
Start date: May 2015
Phase: N/A
Study type: Observational [Patient Registry]

Psychosocial factors and adherence to treatment in patients with hemophilia. A multicenter study. Multicenter cross sectional study of patients with hemophilia and their families

NCT ID: NCT02061033 Recruiting - Hemophilia A Clinical Trials

Global Hemostatic Methods in Hemophilia and Von Willebrand's Disease

GHMHW
Start date: March 2013
Phase: N/A
Study type: Observational

Patients with hemophilia who have the same level of deficient factor(s) may express different severity of clinical presentation and bleeding tendency. Therefore a test which could determine overall hemostasis rather than simple concentration of a single deficient factor may correlate better with clinical phenotype in these patients. The investigators will therefore study the usefulness of global hemostatic methods (endogenous thrombin potential (ETP), overall hemostatic potential (OHP), fibrin clot structure) and microparticles in the prediction of severity of bleeding and estimation of response to the treatment in patients with hemophilia. Since hemophilia patients on prophylactic treatment virtually do not bleed, additional patients who are treated on demand only will be included enabling to study possible modulatory effects of different hemostatic factors (particularly prothrombotic and thrombin activatable fibrinolysis inhibitor (TAFI)) on clinical presentation. The investigators will correlate both those factors and clinical severity with global hemostatic methods. The investigators expect to prove that individual tailoring of the treatment, which may enable lowering the prophylactic dose of factor concentrate without increasing the risk of bleeding, is justified in some hemophilia patients. This approach would reduce the amount of necessary factor concentrate in certain patients and decrease the cost (which represents extensive burden for health care systems) of treatment without potential risk for the patients.

NCT ID: NCT02027779 Recruiting - Hemophilia A Clinical Trials

Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A

Start date: January 2014
Phase: Phase 3
Study type: Interventional

This study primarily will address the safety and secondarily will assess efficacy of GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII).

NCT ID: NCT01856751 Recruiting - Haemophilia Clinical Trials

Use of a TGA and TEM in the Assessment of the Efficacy of Treatment With APCC or rFVIIa

Thrombus
Start date: April 2014
Phase: N/A
Study type: Observational

Occurrence of inhibitors to coagulation factor VIII is diagnosed in ~30% patients with haemophilia A. Presence of inhibitor with a titre >5 BU/ml requires the use of by-passing agents: recombinant activated Factor VIIa concentrate (rFVIIa) and/or activated prothrombin complex concentrate (APCC). Similarly, haemorrhagic complications in patients with acquired haemophilia and inhibitor titre >5 BU/ml should be treated with by-passing agents. Response to treatment with by-passing agents is patient-specific, and can vary in the same patient during subsequent bleedings. Some patients have good response to both products, however in other patients a better bleeding control is provided by one of the mentioned above agents (APCC or rFVIIa). There are clinical situations when severe bleedings requires an alternate use of both these agents. Traditional methods of laboratory tests used post-treatment in patients with haemophilia without inhibitors are useless in the presence of inhibitor. Laboratory monitoring of therapy with by-passing agents is possible with the use of global tests for the coagulation process assessment, which are as follows: thrombin generation assay (TGA) and thromboelastometry (TEM). Several studies revealed that TGA allows a monitoring of therapy with by-passing agents in patients with haemophilia A and inhibitor - the choice of the most effective treatment option - agent type and its dose, as well as laboratory assessment of treatment efficacy. Up to date, laboratory tests assessing the efficacy of by-passing agents in patients with acquired haemophilia were not conducted. In Factor VIII or IX deficiency conditions, fibrin's fibres generated by thrombin are morphologically thicker, and blood clots have increased susceptibility to fibrinolytic enzymes. Blood clot stability may be assessed with the use of thromboelastometry (TEM). We can hypothesize that simultaneous use of TGA and TEM methods may allow for an assessment of patient's individual response to therapy with by-passing agents. Clinical significance of the minimal dose of APCC and rFVIIa, needed to TGA and TEM normalization, requires further studies. Tests' purpose: Examination of the hypothesis that simultaneous use of thrombin generation assay (TGA) and thromboelastometry (TEM) may facilitate the choice of optimal therapy with by-passing agents and laboratory monitoring of efficacy of those agents in patients with acquired haemophilia or haemophilia A with inhibitor.

NCT ID: NCT01808911 Recruiting - Clinical trials for Acquired Haemophilia

Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study)

CREHA
Start date: May 2012
Phase: Phase 3
Study type: Interventional

CREHA project is a study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. The study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for FVIII inhibitor eradication in acquired haemophilia.

NCT ID: NCT01619046 Recruiting - Hemophilia A Clinical Trials

Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A

Start date: March 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety, efficacy and pharmacokinetics of GreenGene™ F in subjects with severe hemophilia A previously treated (> 150 exposure days) with a Factor VIII concentrate and without presence or history of inhibitors to FVIII (Factor VIII).

NCT ID: NCT01505946 Recruiting - Clinical trials for Severe Hemophilia A With Inhibitor

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

PredicTGA
Start date: March 2012
Phase: N/A
Study type: Observational

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.