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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…

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…

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.

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…

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…

Prospective multicenter cohort for evaluation of changes in Immune profile and platelet function after start of TPO-receptor agonist in patients with chronic ITP

To evaluate possible changes in immune profiles and platelet function after start of a TPO-RA.

An open-label, single-arm, multicenter study to evaluate the efficacy and safety of caplacizumab and
immunosuppressive therapy without first-line therapeutic plasma exchange in adults with immune-mediated thrombotic thrombocytopenic purpura

This study has been transitioned to CTIS with ID 2024-513262-19-00 check the CTIS register for the current data. Primary objective:- To evaluate the efficacy of caplacizumab in combination with immunosuppressive therapy (IST) without therapeutic…

A phase I, open-label, single-dose, randomized, cross-over, 3 parts study to evaluate in healthy subjects the relative bioavailability of eltrombopag new capsule formulation (CPS) in comparison to the reference marketed film-coated tablets (FCT) (Part 1), the pharmacokinetic comparability of eltrombopag CPS and marketed FCT (Part 2) and the effect of food on the pharmacokinetics of eltrombopag administered as CPS (Part 3)

- To evaluate the relative bioavailability between the new eltrombopag capsule formulation (CPS) and the marketed tablet formulation (FCT) at single oral doses of 25 mg and 75 mg, in healthy subjects in the fasted state.- To evaluate the PK…

Stop TPO-receptor agonist in ITP Patients

Find/confirm percentage of remission after discontinuing TPO-RA in persistent and chronic ITP patients.

A Phase 3, Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of
B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects with
Congenital Hemophilia A with Factor VIII Inhibitors Undergoing Surgical or Other
Invasive Procedures

To evaluate the perioperative hemostatic efficacy of BAX 802 in male subjects with CHA with inhibitors to human factor VIII (hFVIII) undergoing major or minor elective surgical, dental, or other invasive procedures as determined by the Global…