6 results
The primary objective of the study is to quantitatively determine the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy (hematologic or…
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
The FAST Therapy Trial is a prospective trial of patients with a new diagnosis of fetal SVA aimed to compare the impact of different perinatal treatment strategies from the time of SVA diagnosis to birth or death1) The primary outcome will be the…
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
Digoxin Evaluation in Chronic heart failure: Investigational Study In Outpatients in the Netherlands
To study whether low-level digoxin reduces the composite primary endpoint of (repeated) HF hospitalizations, (repeated) urgent HF hospital visits and cardiovascular mortality, compared to placebo, in chronic HF.