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Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of personalized prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe haemophilia A

Primary Objective• To compare the annualised total bleeding rate of individually tailored prophylaxis with the historical bleeding rate observed in patients having received on-demand treatment with Human-cl rhFVIII from study GENA-01Secondary…

7-day study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties
of oral rivaroxaban in children from birth to less than 6 months with arterial or venous
thrombosis

The primary objective is:- to characterize the pharmacokinetic/pharmacodynamic profile of a 7-day treatment with oral rivaroxabanThe secondary objectives are:- to assess the incidence of major bleeding and clinically relevant non-major bleeding- to…

Observational prospective study to evaluate the efficacy of Vitamin K Intravenously on the coagulopathy in patients with peroxisomal biogenesis disorders (PBD)

Primary objective: To evaluate the effect of intravenous vitamin K therapy on the vitamin K dependent coagulopathy in patients with peroxisomal biogenesis disorders measured with APTT, PT, FV, FVII, fibrinogen, d-dimer, thrombocytes and PIVKA.…

Cross-sectional study on plasma levels of activated protein C and related plasma proteins in Factor V Leiden and Prothrombin Mutation carriers

The primary objective is to determine whether APC is elevated in thrombophilia carriers compared to non-carriers. In parallel we will address. Secondary objectives include assessing whether biomarkers related to angiogenic pathways downstream of APC…

MRI vessel wall characteristics of peripheral arteries and arterial stiffness in hemophilia patients

The primary objective is to analyze and compare morphological (media- thickness) and functional (stiffness) vessel wall parameters of peripheral arteries between hemophilia patients with an ankle- brachial index >= 1.3 and hemophilia patients…

Single-dose, randomized, double-blind, two-way crossover study for the demonstration of pharmacodynamic equivalence of enoxaparin (100 mg/mL) 100-mg subcutaneous injection. Manufactured by Rovi (Spain) to Clexane (100 mg/mL) 100-mg subcutaneous injection manufactured by Sanofi (EU) in healthy volunteers.

The purpose of the study is to investigate the effect on the body of enoxaparin manufactured by the Sponsor (this is called pharmacodynamics) and to compare it with the pharmacodynamic effect of Clexane®. In addition, it will be investigated to what…

A multi-centre, randomised, placebo controlled, double blinded, multiple dose trial investigating safety, pharmacokinetics and pharmacodynamics of concizumab administered subcutaneously to haemophilia A subjects

Primary objective:- To assess the safety of concizumab given as multiple s.c. doses to subjects with haemophilia ASecondary objectives:- To assess pharmacokinetics of concizumab in subjects with haemophilia A after multiple s.c. doses- To assess…

Therapy of Refractory Inhibitors with immUne Modulation in Patients with Hemophilia. The TRIUMPH trial

To evaluate the efficacy, safety and feasibility of combined immune modulation with rituximab, ITI and MSCs in terms of eradication of FVIII inhibitory activity in hemophilia A patients.

The Fear F8ctor Study

To explore the effects of acute fear on the coagulation system while sitting still.

Effectiveness of Forced Air Preoperative warming

The primary objective of the study is to determine whether the use of pre-and intraoperative warming with a forced air technique leads to a reduction of the incidence of hypothermia compared to patients with only intra-operative forced air warming.…

Predictors of Bleeding Evaluation in Adult Hematologic Patients with Bleeding Tendencies
Patients with established bleeding disorders: The BePa verification study

To evaluate the diagnostic accuracy of the experimental tests to detect bleeding disorders and to evaluate whether or not they can be used for monitoring the effects of coagulant factor replacement therapy.

Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B

Primary Objective- To evaluate immunogenicity of N9-GP (nonacog beta pegol)Secondary Objectives- To evaluate safety of N9-GP (nonacog beta pegol)- To evaluate efficacy of N9-GP (nonacog beta pegol) * in long-term prophylaxis treatment * in the…

Blood Outgrowth Endothelial Cells (BOECs) to study the pathophysiology of von Willebrand disease and the feasibility of in vitro correction of von Willebrand factor defects

1. To establish optimized approaches for the isolation and characterization of BOECs and iPSC-ECs2. To further explore the biology of VWF, the pathophysiology of different subtypes of VWD and the role of VWF as a signalling protein in for example…

DDAVP treatment combined with FVIII clotting factor concentrates in patients with mild hemophilia A.

Primary objectives:To assess the proportion of non-severe hemophilia A patients within FVIII target levels with the DDAVP and FVIII concentrate combination treatment in the first 72 hours after the start of combination treatment, without adding off-…

Advanced diagnostic management of suspected recurrent ipsilateral deep vein thrombosis of the leg with magnetic resonance direct thrombus imaging - The Theia study

The primary objective of the study is to assess the safety of a normal MRDTI to rule out acute, recurrent ipsilateral proximal DVT in a prospective, multicenter, single-arm management (cohort) study.Secondary objectives are:1.To evaluate the safety…