8 results
The main objective of this study is to test the effects of combined SGLT1 and SGLT2 inhibition with sotagliflozin on hemoconcentration and plasma volume in patients with heart failure.
The purpose of the study is to compare LA-EP2006 and Neulasta®US and Neulasta®EU with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called…
The purpose of the study is to investigate the ability of MYL-1401H to evoke an immune response (immunogenicity) as compared to Neulasta® US. In addition, the effect of MYL-1401H on blood cells as compared to Neulasta® US will be investigated. The…
The purpose of the study is research. The study investigates to what extent ANF Rho is tolerated in comparison to Neulasta® (representing standard of care treatment) and placebo. A placebo is the same formulation as the study medication without the…
In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…
The main objectives of the study are to demonstrate whether sotagliflozin reduces the composite of CV (cardiovascular) death and HHF (hospitalization for heart failure) as compared to placebo in diabetic patients after admission for WHF (worsening…
1) To assess uptake of [18F]BMS-986192 in tumor lesions before and after treatment with nivolumab, in relation to [18F]-FDG uptake as potential whole body biomarker for response. 2) To evaluate safety and tolerability of neoadjuvant nivolumab 3) To…
This study is designed to demonstrate the CV and renal effects of sotagliflozin in patients with T2D, high CV risk, and moderate renal impairment. One of the major objectives of this study is to fulfill the regulatory mandate that any new therapy…