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Recovery and survival of platelet concentrates in plasma and in 3 additive solutions

The objectives of this study is to determine the recovery and survival of platelet concentrates; in the first phase, a comparison will be made for platelet concentrates in plasma stored for 2-3 days versus those stored for 6-7 days; in the second…

A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura.

• The primary objective of this study is to assess the long term safety of fostamatinib in subjects with persistent/chronic ITP.• The secondary objectives of this study are to establish the long-term efficacy of fostamatinib in achieving and…

Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato-oncological patients;Pathogen Reduction Evaluation & Predictive Analytical Rating Score (The PREPAReS Study)

A prospective randomized phase III clinical trial to study the effectiveness of pathogen-reduced platelet concentrates in plasma, stored for up to 7 days, and compare these with untrested platelet concentrates in plasma, stored for up to 7 days. The…

A Phase 1, Prospective, Open Label, Two Period, Fixed Sequence, Dose-Escalation Study of the PK and Safety of BAX 826 (PSA-rFVIII) in Previously Treated Patients with Severe (FVIII <1%) Hemophilia A: Protocol number: 291501

1. To assess tolerability and safety of BAX 826 after a single infusion in previously PTPs with severe hemophilia A.2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE.3. To evaluate the impact of anti- PSA antibodies…

Managing Thrombocyte transfusions in a Special Subgroup: NEonates

To assess whether a higher prophylactic platelet transfusion threshold is superior to the lower thresholds in reducing the proportion of patients who experience a major bleed or death up to study day 28.

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura).

Core Study:Primary objective: • To demonstrate that the efficacy of E5501 (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic…

A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus
Eltrombopag, in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)

Core StudyPrimary objective• To compare the efficacy of E5501 (in addition to standard of care) to eltrombopag (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic…

Platelet transfusions in neonates

Determination of non-inferiority of volume-reduced platelet concentrates compared to plasma platelet concentrate in terms of recovery. To assess safety (bleeding and thrombotic complications, and adverse transfusion reactions) and transfusion…

Effects of low-dose aspirin taken at bedtime vs. on awakening on circadian rhythm of platelet function in healthy subjects

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.

A randomized, double-blind, placebo-controlled, 4-period cross-over drug-drug interaction study to evaluate the effect of sugammadex and aspirin on platelet aggregation and coagulation parameters in young healthy male volunteers

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.

An Open Label Study of AMG 531 in Severely Refractory Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Primary:To demonstrate the safety of AMG 531 in severely refractory thrombocytopenic subjects with ITPSecondary:To monitor hematological responses to AMG 531To provide open-label use of AMG 531, and to investigate its utility in severely refractory…

Platelet function preservation after intraoperative autologous blood donation in cardiac surgery

To reduce postoperative blood loss by improving platelet function in autologous blood donation

Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with Raptiva (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST).

PrimaryTo assess the prevalence of anti-efalizumab positivity in two sub-populations of psoriatic subjects trated with Raptiva® in the framework of the CLEARESTTM study:- Subjects developing adverse events (AEs) corresponding to pre-specified newly…

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

• The primary objective of this study is to establish the efficacy of fostamatinib as compared with placebo in achieving a stable platelet response in subjects with persistent/chronic ITP.• Secondary objectives include assessment of the incidence of…

A phase 3 prospective, multicenter study to evaluate efficacy and safety of rVWF with or without ADVATE in elective surgical procedures in subjects with severe von Willebrand disease

The primary objective of this study is to assess the hemostatic efficacy and safety of rVWF with or without ADVATE in subjects (* 18 years) diagnosed with hereditary severe VWD undergoing major and minor elective surgical procedures.

An international, multicenter, randomized, double-blind, placebocontrolled
phase 3 trial investigating the efficacy and safety of rivaroxaban
to reduce the risk of major thrombotic vascular events in patients with
symptomatic peripheral artery disease undergoing lower extremity
revascularization procedures

The primary efficacy objective of the study is:* to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducingthe risk of major thrombotic vascular events (defined as MI, ischemic stroke, CVdeath, ALI, and major amputation of a…

Phase 3, prospective, multi-center, open label study to investigate
safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII
(BAX 855) in previously untreated patients (PUPs) < 6 years with
severe hemophilia A (FVIII < 1%)

Primary Objective:The primary objective of the study is to determine the safety including immunogenicity of BAX 855 based on the incidence of inhibitor development to FVIII (* 0.6 Bethesda unit (BU)/mL using the Nijmegen modification of the Bethesda…

An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of Rilzabrutinib (PRN1008), an Oral BTK Inhibitor, in Patients with Relapsed Immune Thrombocytopenia

This study has been transitioned to CTIS with ID 2023-509397-39-00 check the CTIS register for the current data. Part A: Safety:• To characterize the safety and tolerability of up to four dose levels of rilzabrutinibin patients with ITPEfficacy:• To…

An Open Label Extension Study of Voxelotor (GBT440) Administered Orally to Participants with Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials

The objective of this open-label extension (OLE) study is to assess the effect of long-term safety and treatment effect of Voxelotor in participants who have completed treatment in Study GBT440-031, using the following parameters:- Safety based upon…

How does pneumatic tube transportation of thrombocyteconcentrates for transfusion purposes influence the thrombocyte in vivo function?

Aim of the study is to show the feasibility of pneumatic tube transport of thrombocyte concentrates. The efficacy will be measured by thrombocyte increment (CCI) and thrombocyte funtion analysis. This shall lead to routine transportation of TC*s to…