11 results
Primary Objective:The objective of this pilot study is to determine whether the observed AP pharmacokinetic profiles in plasma of CABG patients in the APPIRED study can be confirmed in the CABG patients under a non-aprotinin regime.
To establish the safety and and tolerability and early efficacy of Alkaline phosphatase in the treatment of sepsis patients with renal failure.
Primary Objective:The objective of this study is to determine the efficacy of bIAP as a prophylactic agent against inflammation-mediated complications from more invasive cardiac surgery, aortic valve surgery and CABG with cardiopulmonary-bypass time…
The primary objectives of the study are as follows:• To investigate the effect of recAP on renal function and related clinical parameters in patients with SA-AKI.• To determine the therapeutic dose(s) of recAP to support the pivotal Phase 3 program.…
To 1) clinically validate the novel PET-tracer [18F]AV1451 for tau pathology as a diagnostic and prognostic marker in tauopathies, 2) to examine the (change in) (regional) binding of [18F]AV1451 across tauopathies, and the relationships between (…
To assess efficacy and safety of ivosidenib/enasidenib vs. placebo in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic…
The primary objective of this study is to:• Determine the safety and tolerability of AG-120 and AG-221 when administered with induction and consolidation therapy in patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate…
The purpose of this study (APPIRED III) is to investigate the efficacy of administered prophylactically RESCAP with regard to the prevention of (severe) renal failure, or renal dysfunction, reducing morbidity and mortality. It also looks at systemic…
Based on results from a comparative review (Paoletti 2013), we hypothesize that if the toxicity profile and the PK parameters observed in children treated at the adult RP2D are similar to those in adults; escalating to the MTD is not necessarily…
To determine whether [18F]FES PET/CT improves staging for women with clinical stage II/III or LRR, ER+ breast cancer as compared to standard [18F]FDG PET/CT.
Phase 1b Dose-finding Stage Primary Objectives· To assess the safety and tolerability of the combination treatments of oral AG-120 when administered with subcutaneous (SC) azacitidine and oral AG-221 when administered with SC azacitidine in subjects…