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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.

Efficacy and Safety of NNC 0129-0000-1003 during Surgical Procedures in Patients with Haemophilia A

Primary Objective: * To evaluate the haemostatic effect of N8-GP during surgical procedures in patients with haemophilia A. Secondary Objectives * To evaluate the general safety including immunogenicity of N8-GP when used for prevention and…

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…

30-day, single-arm study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children with various manifestations of venous thrombosis.

-Assess the incidence of major bleeding and clinically relevant non-major bleeding -Assess the incidence of recurrent venous thromboembolism -Characterize the pharmacokinetic/ pharmacodynamic profile of a 30-day treatment with oral rivaroxaban

Perioperative Management of Patients who are Receiving a Novel Oral Anticoagulant (Dabigatran, Rivaroxaban or Apixaban) and Require an Elective Surgery or Medical Procedure: A Prospective Cohort Study (PAUSE)*

1.1 Overall Aim: To establish a safe, standardized protocol for the perioperative management of patients with atrial fibrillation (AF) who are receiving a novel oral anticoagulant (NOAC) drug, either dabigatran, rivaroxaban or apixaban, and require…

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

Bloodloss study after Aortic valve replacement
Impact of Mecc perfusion vs conventional ECCperfusion

Peri-operative Bloodloss after Aortic valve replacement

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…

An Open-Label Study of the Safety and Efficacy of ReFacto AF in Previously Untreated Patients in Usual Care Settings

The primary objective is to evaluate the safety of ReFacto AF in previously untreated patients (no prior exposure to factor products or any blood products) of less than 6 years of age.

Bone density as outcome parameter in haemophilia treatment

• Compare bone density between patients with mild haemophilic and those with severe haemophilia*.• Compare the relationship between treatment regimen: prophylactic (high-dose vs. intermediate dose) and on-demand and bone density.• Examine the…

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…

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…

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.

INFLUENCE OF LIDOCAINE UPON CELLULAR COAGULATION: IN VITRO INVESTIGATIONS USING THE
MULTI-PLATE® THROMBOCYTE AGGREGOMETER

The aim of the present study is therefore to investigate the commonly used LA lidocaine in its ability to attenuate thrombocyte aggregation in vitro.

Thrombogenesis in antipsychotics

Is there an increase in markers of trombogenese (platelet activation, d-dimeer, von willebrandfactor, OPG) in elderly users of antipsychotics six to ten days after the start in comparison to the same markers before start of the antipsychotic…

Pharmacokinetics of nAdroparin in venous thromboembolism Prophylaxis in critically ill pAtients - an observational pilot study

Primary objective: to quantitatively characterize the pharmacokinetics and associated inter-individual and inter-occasion variability of prophylactic nadroparin in critically ill patients.Secondary objectives: To screen and possibly quantify the…

A Phase Ib, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients

To assess the Pharmacokinetic and Pharmacodynamic properties of three dosages of Coagulation Factor VIIa (Recombinant) in congenital hemophilia A or B patientsTo assess the safety of three dosages of Coagulation factor VIIa (Recombinant) in…

Evaluation of the effect of aspirin on platelet aggregation and coagulation parameters in healthy male volunteers

-To assess the feasibility of relatively frequent measurements of whole blood platelet aggregometry using collagen as inducer;-To assess the effects of ASA treatment on collagen-induced platelet aggregation (primary endpoint);-To investigate the…

Nadroparin use in critically ill patients on the ICU ward: safe and steady form of coagulation?

We want to investigate if in critically ill patients use of LMWH is associated with stable plasma levels of anti-Xa activity. Furthermore, we want to investigate if GFR and circulation influence anti-Xa activity and which complications can occur.…