Search for a trial

A randomized, open-label, 4-group, 2-period replicate design study to evaluate within- and between-subject variability in exposure of two lots of E5501 20 mg tablets administered as single doses of 40 mg, in the fasted and fed conditions to healthy subjects.

Primary :to determine whether concomitant administration of the study drug with food reduces within- and between-subject variability in exposure as measured by area under the plasma concentration-time course profile (AUC) and maximum observed plasma…

Cerebral imaging in adults with sickle cell disease using ultra high field magnetic resonance imaging

To determine whether pathological changes are visible in brain parenchyma, blood vessels or other intracranial structures on ultra high field MRI in SCD patients in normal anatomical areas on 3.0 Tesla MRI and to determine the nature of these…

Chronic disease in Immune Thrombocytopenia of Childhood

The primary objective of this study is to identify parameters that predict bleeding risk in children with chronic ITP. Secondary objectives are: 1) To investigate whether children with long lasting chronic ITP differ from children with newly…

An open-label, uncontrolled, multicenter, multinational study on the efficacy and safety of administration of donor lymphocytes depleted of alloreactive T-cells (ATIR), through the use of TH9402 and light treatment in an ex vivo process, in patients receiving a CD34-selected peripheral blood stem cell graft from a related, haploidentical donor.

Primary objective:• To study the effects of the administration of a donor lymphocyte preparation selectively depleted of host alloreactive T cells (ATIR) to patients with hematologic malignancies on 6 months and 12 months transplant related…

CHANGES IN THE COAGULATION CASCADE IN PATIENTS WITH PROGRESSIVE (METABOLIC) LIVERDISEASE

The objective of this study is to investigate if the Thrombin Generation Curve has an additional, possible more accurate, value besides the conventional tests such as PT, APTT, INR, AT and the mearument of coagulationfactors for determining…

An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 during Surgical Procedures in Patients with Haemophilia B

Primary Objective: To evaluate the haemostatic effect of N9-GP during surgery procedures in patients with haemophilia B.Key Secondary Objectives• To evaluate the haemostatic effect of N9-GP during surgery and the postoperative period.• To evaluate…

Protocol CV185074: evaluation of multiple dose pharmacokinetics and pharmacodynamics of apixaban and rivaroxaban in healthy subjects

Primary:- to assess the multiple-dose pharmacokinetics of apixaban and rivaroxaban - to compare plasma concentration peak to trough ratio (Cmax/Cmin) of rivaroxaban to apixaban Secondary:- to assess the multiple dose pharmacodynamics (anti-Factor Xa…

The CPB; fibrinoLysis Or Thrombosis? (CLOT) study, understanding the effects of CPB on coagulation and fibrinolysis to improve treatment of blood loss after cardiac surgery.

The aim of the study is to understand the effects of CPB on coagulation and fibrinolysis to improve treatment of excessive blood loss (>2L/24 hours or >200 mL/hour) after cardiac surgery.The objective of this study is to differentiate…

Hemostasis of oral surgery wounds with the HemCon dental dressing in patients on oral anticoagulation therapy

Testing the hemostasis of oral surgery wounds with the HemCon dental dressing in patients on oral anticoagulation therapy

A Phase 1 Study to Compare the Pharmacokinetics of CAL-101 Capsules to Tablets in Healthy Male Subjects.

Primary: to evaluate the pharmacokinetics of a single 100 mg dose of CAL-101 administered as a capsule (unmicronized formulation), a capsule (micronized formulation) or a tablet in normal healthy male subjectsSecondary: to evaluate the safety of a…

Erythrocytapheresis versus Phlebotomy as maintenance therapy in patients with hereditairy hemochromatosis; a randomised, single blinded, sequential, cross-over trial

The primary objective of the study is to determine the gain in effectiveness of TE compared with P when applied to remove excess iron during maintenance therapy of HH patients.

A Phase I Study to Evaluate the Safety and Tolerability of the Histone Deacetylase Inhibitor, CHR-2845, in Patients with Advanced or Treatment Refractory Haematological Diseases or Lymphoid Malignancies

Primary objective:* To determine the safety, tolerability, dose-limiting toxicities (DLT), maximum acceptable dose (MAD) and maximum tolerated dose (MTD) of CHR-2845 when administered orally to patients with advanced or treatment refractory…

Co-infusion of haematopoietic stem cells from a haplo-identical donor and single unit unrelated cord blood in patients with a high risk of relapse:
A Phase l/ll study to assess safety and to investigate the biological mechanism of the anti-tumor response

To study the safety of co-infusion of a alphabetaT-/CD19 B-cell depleted haematopoietic stem cells from haplo-identical donor and a single unit cord blood unit and to investigate the anti-tumor responses from both grafts.

Immune Tolerance Induction study in patients with severe type A haemophilia
with inhibitor after failure of a previous induction of immune tolerance with
FVIII concentrates without Von Willebrand factor. (RESIST-EXPERIENCED)

Evaluate whether FVIII/VWF concentrates successfully induce immune tolerance in patients who have already experienced and failed immune tolerance induction with VWF-free FVIII concentrates.

Prevalence of FXI gene mutations in women with menorrhagia.

to investigate the presence and frequency of FXI gene mutations in patients with menorrhagia and healthy volunteers.

Role of flow cytometry in the assessment of restoration of hematopoiesis during standard Exjade® treatment in patients with low- intermediate I risk myelodysplastisc syndromes, a pilot study

- Primary objective:To evaluate the flow cytometric characteristics of the bone marrow compartment before and during treatment with Exjade® in low and intermediate-I risk myelodysplastic syndromes.- Secondary objectives:To correlate the flow…

Finding early Indicators of Neurological Damage in Sickle Cell Disease

Main objective of the current study is to evaluatie clinical, laboratory and genetic risk factors associated with prograssion of neurological damage. The final objective is to make a prognostic model of these risk factors to predict early…

ADDED VALUE OF 18FDG-PET-CT IN THE DIAGNOSIS OF INVASIVE FUNGAL INFECTIONS IN NEUTROPENIC PATIENTS

Objective: The primary objective of this pilot study is to compare FDG-PET-CT with HR-CT alone and to HR-CT and galactomannan test together for early diagnosing IFIs in neutropenic patients.

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Siltuximab Plus Best Supportive Care to Placebo Plus Best Supportive Care in Anemic Subjects with International Prognostic Scoring System Low- or Intermediate-1-Risk Myelodysplastic Syndrome

The primary objective is to assess the clinical efficacy of siltuximab (a chimeric (murine-human) IgG1* mAb that specifically binds human IL-6 with high affinity and prevents its interaction with the IL-6 receptor, glycoprotein (GP) 80),…

Idiopathic non-cirrhotic intrahepatic portal hypertension (INCIPH): assessment of thrombophilia and histopathology in a multicentre cohort study and HIV patients.

Objevtive of the study is to analyze a European cohort of patients with INCIPH based on scientific analyses of clinical, laboratory and morphological data prospectively collected. HIV patients with known splenomagaly will be invited for abdominal…