78 results
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…
Objective of the study is to measure dabigatran trough levels, percentage of dabigatran glucuronidation, and diluted thrombin time, to test whether these levels are different in elderly patients.
To obtain blood samples from twenty-one adult hemophilia A patients with and without inhibiting FVIII antibodies for biochemical analyses in order to show the efficacy and determine the potency of recombinant FIX-FIAV treatment using thrombin…
To determine and compare plasma levels of rivaroxaban during daytime with a morning and evening intake in patients treated for venous thromboembolism
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-…
ThThe primary efficacy objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non-inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent VTE in patients with cancer who have completed at…
Primary objective:To investigate the safety of turoctocog alfa pegol during continuous use for prevention and treatment of bleeding episodes of previously turoctocog alfa pegol treated severe haemophilia A patients.Secondary objectives:To…
The primary efficacy objective is to assess the incidence of symptomatic recurrent venous thromboembolism.The secondary efficacy objective is to assess the incidence of symptomatic recurrent venous thromboembolism and asymptomatic deterioration on…
Our aim is to assess the sequential response of different endothelial markers following DDAVP administration. This information will be used to expand the population PK model and may enhance our insight in the mechanisms underlying the DDAVP response…
The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…
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…
Primary objectives: To evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ISIS 416858 (200, 250, and 300 mg once weekly) as compared to placebo.Exploratory Objectives: Incidence of myocardial infarction (MI), stroke, systemic…
The main objective is to collect data on effect size for, and determine the feasibility of, a full scale RCT to assess the effect of dosing per 0.5 mg acenocoumarol on quality of anticoagulation, treatment satisfaction, and medication errors.
Primary Objective: To assess the ex-vivo anticoagulant potency of Edoxaban in patients with Child Pugh A/B cirrhosis, by means of percentual changes in ex-vivo thrombin generation from baseline compared to steady state. These results will be…
1. Evaluation of the change in immunologic profile after switch to a different FVIII product, ie analysis of (FVIII specific) B- and T-cell subtypes, amount and function of regulatory T cells (Tregs) and cytokine production. 2. Determining the risk…
The primary objective of this study is to investigate the safety of systemic administration of AAV5-hFIX, an adeno-associated viral vector containing a codon-optimized hFIX gene, to adult patients with severe or moderately severe haemophilia B.…
The ATLAS-A/B trial (ALN-AT3SC-004) is a multicenter, multinational, randomized, openlabel Phase 3 study designed to demonstrate the efficacy and safety of fitusiran in patients with hemophilia A or B without inhibitory antibodies to FVIII or FIX…
Therapeutic nadroparin administration:Primary objective: To develop evidence-based dosing regimens of nadroparin for children in different age groups by means of the objectification of the PK/PD of nadroparin.Secondary objective: 1) Investigate the…