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A Phase 3 clinical study to determine the pharmacokinetics, safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding episodes in subjects diagnosed with von Willebrand disease

Primary objective:• Assess the pharmacokinetics (PK) of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary VWDSecundary objectives:• Compare the…

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…

Randomised trial to investigate possible differences in biological availability and effectiveness between vitamin K solution in oil and vitamin K tablets.

1. Determining whether or not the vitamin K tablets have the same biological availability in humans as the vitamin K solution has.2. Determining whether or not the vitamin K tablets are as effective as the vitamin K solution is.

EDOXABAN SWITCHING STUDY FOR APIXABAN

Primary :To evaluate the prothrombin time (PT) in healthy volunteers treated with edoxaban alone or preceded by apixaban.Secondary : To assess the effect of edoxaban alone or preceded by apixaban on additional pharmacodynamic (PD) assays: activated…

ABILITY OF PROTHROMBIN COMPLEX CONCENTRATE (COFACT ®) TO REVERSE THE ANTICOAGULANT EFFECT OF NOVEL ANTITHROMBOTIC AGENTS

Study questionWhat is the effect of a single administration of prothrombin complex concentrate (CoFact) on the anticoagulant effect of a novel oral thrombin inhibitor (Dabigatran) and a novel oral factor Xa inhibitor (Rivaroxaban) in healthy human…

Oral Thyroid hormone In Healthy volunteers Study: an interventional study on the effect of thyroid hormone on coagulation and fibrinolytic parameters.

Primary objective:- To define the overall effect of oral Levothyroxine on coagulation parameters.Secondary objectives:- To define the specific effect of Levothyroxine on each tested coagulation parameters.- To define the specific effect of…

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…

The Fear F8ctor Study

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

A multi-centre, comparative, double blind, randomised cross-over trial investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A

Primary objectiveTo evaluate and compare the single-dose pharmacokinetic of turoctocog alfa pegol from the pivotal process with turoctocog alfa pegol from the commercial process, each given as intravenous administrations of 50 U/kg to patients with…

Flow augmentation study

Primary Objective: The primary objective of this study is to identify whether the Geko system can augment flow compared to IPCS in post-thrombotic limbs before after stenting.(group 1) In group 2 we want to identify whether the Geko with occluded…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary
Angioedema Type I or I

Primary Objective: To demonstrate the clinical efficacy of KVD900 compared with placebo for the on-demand treatment of HAE attacks.Secondary Objective: To investigate the safety and tolerability of KVD900.

Health effects due to inhalation of ultrafine particles in healthy volunteers. Multiple short-term exposures to UFP near Schiphol Airport.
A cross-over study

We hypothesize that the toxic potency of UFP from air traffic is comparable to road traffic after inhalation by healthy humans. Therefore, we aim to:* Identify acute effects of short-term inhalation of ultrafine particles right next to Amsterdam…