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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…

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.

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…

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…

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.

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…