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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…

Prothrombin complex concentrate in the reduction of blood loss during orthotopic liver transplantation.

To investigate in a randomized controlled trial, whether giving Cofact pre-operatively can reduce the bloodloss and transfusion requirements during orthotopic liver transplantation. Also we investigate the safety of Cofact in this patient population…

Effect of Carbon Nanoparticles on Inflammation and Coagulation after Bronchial Segmental Instillation. A dose escalation study

We will investigate the local and systemic effects of carbon nanoparticles on inflammation and coagulation in humans by bronchial segmental challenge

A Phase I, Dose Escalation Study on the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) and its Comparability to NovoSeven® in Healthy Male Volunteers Pre-Treated with Fondaparinux

A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.

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…

Randomized, active-controlled, double-blind, parallel design study to evaluate the efficacy and safety of a once-a-week prophylaxis treatment with BAY 79-4980 compared to three times-per-week prophylaxis with rFVIII-FS in previously treated patients with severe hemophilia A

The primary objective is to evaluate the effect of a once-a-weekprophylaxis regimen with BAY 79-4980 on the protection from all bleeds compared to a three times-per-week prophylaxis regimen with rFVIII-FSWFI.

The influence of ACTH on blood coagulation

The primary objective of this clinical controlled trial is to define the overall effect of adenocorticotropic hormone on coagulation parameters in patients with primary adrenal insufficiency (as diagnosed by their physician by previous short ACTH…

A randomised, double blind placebo controlled trial to (A) assess the optimal vitamin K dosage for supplementation, and (B) to access wether complications of anticoagulation treatment will diminish by suppletion of vitamin K.

VIKS-2A:To determine the optimal dosage of vitamin K for supplementation to obtain a stable anticoagulation effect.VIKS-2B:To determine whether supplementation with the found optimal dosage of vitamin K from study VIKS-2A will decrease the number of…

Fibrinogen therapy for massive blood loss during elective surgery for craniosynostosis repair, a double blinded randomized controlled study

Primary outcome parameter is the amount of intra- and postoperative transfusions required. Secondary outcome parameters include intra- and postoperative blood loss, operation time, and postoperative complications and the outcome of…

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…

Comparison of a single dose fibrinogen with placebo and the number of blood transfusions after ascending aorta surgery (FIBTEG study)

The purpose of this study is to answer the following question: Leads a primary coagulation corrected with a single dose of fibrinogen concentrate after ascending aorta-arc reconstruction to a decrease in the number of allogenic blood transfusions,…

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of Ravulizumab in Adult and Adolescent Participants who have Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT)

This study has been transitioned to CTIS with ID 2023-510107-22-00 check the CTIS register for the current data. To assess the efficacy of ravulizumab versus placebo in the treatment of adult and adolescent participants with HSCT-TMA.

Tranexamic acid during excisional burn surgery

This study has been transitioned to CTIS with ID 2024-513573-49-00 check the CTIS register for the current data. The objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces the volume of blood loss and number of…

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger

PrimaryTo assess the efficacy of ravulizumab in the treatment of participants with TMASecondaryTo characterize TMA responseTo assess impact on hemoglobin levels To evaluate change in kidney function To assess duration of Complete TMA Response and…

Peroperative Administration of Tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce hemorrhage rates (PATRY study): a randomized controlled trial

This study has been transitioned to CTIS with ID 2024-513570-22-00 check the CTIS register for the current data. This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo metabolic…

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered Prothrombin Complex Concentrate (PCC) in Combination with a Selected FXa Direct Oral Anticoagulant (FXa DOAC) in Healthy Subjects.

Primary objective:• To assess, in healthy subjects, the pharmacodynamic (PD) properties of PCC in the presence and absence of selected DOACs.Secondary objectives:• To assess, in healthy subjects, the safety and tolerability of PCC in the presence…

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.

Peroperative Administration of Tranexamic Acid in Sleeve gastrectomy (PATAS) to reduce hemorrhage rates

This trial aims to investigate if peroperative administration of TA can reduce the peroperative and postoperative hemorrhage rates in laparoscopic sleeve gastrectomy.

Randomized placebo-controlled pilot study to determine the effect of probiotics on vitamin K status in renal transplant recipients

To investigate the effect of a daily sachet of probiotics for 12 weeks vs placebo on vitamin K status in renal transplant recipients.

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ISIS 416858 (IONIS-FXIRX an Antisense Inhibitor of Factor XI), Administered Subcutaneously to Patients with End-Stage Renal Disease on Hemodialysis

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…