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Response to DDAVP In mild Hemophilia A patients, in Search for dEterminants

The aim of this project is to investigate the association between clinical and genetic factors and DDAVP response in MHA patients and to determine their relative contributions to the DDAVP response.

Treatment of severe acute GVHD after allogeneic hematopoietic stem cell transplantation with steroids versus MSC and steroids.
A prospective double-blind placebo-controlled randomized phase III trial

To improve the response rate to treatment of severe acute GVHD (grade II-IV with gut involvement ) by adding infusion of Mesenchymal Stroma Cells to standard high dose prednisolone.

Treatment of severe steroid-refractory acute GvHD with mesenchymal stromal cells.
A phase III randomized double-blind multi-center HOVON study.

Primary objective* To improve the response rate to treatment of severe steroid-refractory acute GvHD grade II-IV (with gut and/or liver involvement) by early addition of MSC to standardized second line treatmentSecondary objectives* To study the…

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

The primary objective of this study is to evaluate the efficacy of roxadustat compared todarbepoetin alfa in the treatment of anemia in non-dialysis dependent Chronic Kidney Disease (NDD-CKD)subjects.The secondary objectives of this study are to:*…

A phase I, multicenter, open-label study of oral LGH447 in patients with acute myeloid leukemia or high risk myelodysplastic syndrome (CLGH447X2102)

Primary: To determine the MTD and/or RDE of LGH447 with or without midostaurin. Secondary: 1. To characterize the safety and tolerability of LGH447 with or without midostaurin at the MTD and/or RDE.2. To assess any observed antitumor activity of…

An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A

An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A.…

A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis

Comparison of steady-state cysteamine-trough WBC cystine levels between Cystagon® and RP103 over 3 months for each treatment period.

An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant, Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B.

Primary: The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophilia B.Secondary: The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of…

intra-individual platelet activation, as meased by PFA-200, at different time lapses after aspirin intake

To eveluate the effect of amount of time past after last aspirin intake on platelet activability

Reducing the incidence of daily life pain in patients with sickle cell disease

In this study the effect of the administration of NAC on the frequency and severity of pain and painful crises in daily life will be assessed as well as the related frequency and length of hospital admissions and health related quality of life. In…

Effect of three B-cell inhibitors: rituximab, alemtuzumab and bortezomib on anti-A and/or anti-B titer kinetics.

The goal of this study is to find out which B-cell inhibitor results in the best reduction of anti A/B antibody levels at which time interval, to make the best choice for a particcular drug in the desensitization treatment in patients receiving an…

Prevalence of bleeding disorders in women with menorrhagia

Main: To confirm the findings of our previous, explorative study that the overall FXI plasma levels in patients with menorrhagia are lower than in controls. Secondary: To establish the prevalence of FXI mutations/polymorfisms in patients with…

Effect of anticoagulants or procoagulants on thrombin generation in PPP, PRP and whole blood

The main objective is to determine the effect of different anticoagulant and procoagulant agents on thrombin generation in whole blood and compare it to the effect on thrombin generation in PPP and PRP at different tissue factor concentrations. In…

MAGNITUDE-A Phase 3 Evaluation of the Safety and Efficacy of Lambda/RBV/DCV in Treatment Naïve Subjects with Chronic HCV Infection, who have Underlying Mild or Moderate Hemophilia or Patients who are Prior Relapsers to Pegylated interferon alfa/RBV;Revised Protocol 01 Incorporates Amendment 02 and Administrative Letter 01 and 02;+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0, dated 11-Sep-12)

Primary Objectives:The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with GT-1b, -4 and GT-2, -3.Secondary…

Hemophilia Inhibitor PUP Study

Primary Objectives:- Evaluate changes in the immune system upon exposure to FVIII in patients with severe hemophilia A - Identify immunologic predictors of FVIII inhibitor development or tolerance

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Primary Objective:To compare the efficacy of pacritinib with that of Best Available Therapy (BAT) in patients with PMF, PPV-MF, or PET-MF; the efficacy measure for this analysis is the proportion of patients achieving a * 35% reduction in spleen…

The microcirculation in neonatal adaptation, an observational study.

The primary objective in this observational study is to determine microcirculatory profile in preterm and term neonates. We would like to determine how the microcirculation changes in time during the phase of adaptation and correlate inter- and…

Peroperatieve researchstudy with de ROTEM machine to hemostase of patients during aorta abdominalis aneurysm operation.

Objective of the study:Investigating with use of the classical coagulation tests on one hand and with the ROTEM on the other hand what is exactly becoming disturbed in the coagulaton because of bleeding during surgery of the aorta abdominalis,…

Central Hemodynamics, Augmentation index and Microcirculation after Phlebotomy

Our principal aim is to assess the effects of phlebotomy on aortic augmentation (AIx) and central BP in supine position and after standing; second, to assess the effects of counter maneuvers (leg crossing and thigh compression) on aortic…

Mont Blanc: where red meets white: The effect of altitude on thrombin generation

Primary Objective: The primary objective is to investigate the effect of hypoxia on blood coagulation using different techniques, among others the very sensitive TG assay in whole blood and plasma.Secondary Objective: The secondary objective is to…