22 results
STUDY OBJECTIVESTo determine whether NAC therapy results in decreased red cell PS exposure, endothelial activation, inflammation, and reduction clotting activation in the steady state.
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…
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…
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…
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…
To investigate the potential of an interaction between 4 mg/kg sugammadex and aspirin on platelet aggregation using collagen-induced whole blood aggregometry in young healthy male volunteers.
Serum hepcidin levels are elevated in hemodialysis patients and may contribute to functional iron impairment and thus to ESA-resistance. Kinetics of hepcidin in hemodialysis patients has not been studied in detail. This study is designed to provide…
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.
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…
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…
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.
To study the effect of 80 mg aspirin intake at bedtime compared with 80 mg aspirin intake on awakening on circadian rhythm of platelet function in healthy subjects.
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…
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…
To explore the effects of acute fear on the coagulation system while sitting still.
The purpose of the study is to compare LA-EP2006 and Neulasta® with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called pharmacokinetics). It…
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 purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…
The purpose of the study is to investigate to what extent DA-3880 is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to the above mentioned Aranesp® formulation. In addition, the effect DA-3880 on the number of…
The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib (pooled once daily [QD] and twice-daily [BID] dosing arms) with that of best available therapy (BAT) in patients with thrombocytopenia and primary…