9 results
To measure the effect of intravenous ferric carboxymaltose treatment on exercise tolerance, microvascular perfusion and perioperative hemostasis in patients with mild iron deficiency anemia undergoing arterial vascular surgery.
The primary objectives of this study are as follows:* To assess the safety and tolerability of escalating single and multiple doses of GS-5745 in subjects with moderate to severe ulcerativecolitis (UC) as assessed by adverse events (AEs), and…
Secondary objectives are to evaluate the effect of intravenous FCM compared to pla¬cebo on:1. Evolution from baseline of cardiac function parameters as assessed by 2D Echo/Doppler cardiography 4, 12 and 24 weeks after start of study treatment.2.…
The purpose of this study will be to examine the effect of ferrous fumarate or ferinject in patients after a caesarean section with a hemoglobin level between 5.0. and 7.0 mmol/L.The primary outcome measure will be the hemoglobin level at 3 and 6…
Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…
Primary Objective(s)* To evaluate, relative to placebo, the effect of intravenous (IV) FCM on repeated heart failure (HF) hospitalisations and cardiovascular (CV) death.Secondary Objective(s)* To evaluate, relative to placebo, the effect of IV FCM…
Primary- Part A: Evaluation of pharmacodynamic (PD) interaction between steady-state treatment with padsevonil (PSL) and ethanol- Part B: Evaluation of pharmacokinetic (PK) interaction between steady-state treatment with padsevonil (PSL) and…
To study the effects of FCM on exercise tolerance, haematinic parameters, quality of life, cardiac function, muscle function, bone and mineral parameters, microbiota, the immune system, the incidence of infections, allograft failure and mortality in…
Asses whether, in patients with heart failure with preserved ejection fraction and iron deficiency, ferric carboxymaltose improves leftventricular diastolic function and skeletal muscle function by improving energy metabolism