61 results
PART A: To assess the efficacy of BAY 94-9027 in prevention and treatment of bleeding at different infusion schedules.PART B: To assess the safety and efficacy of BAY 94-9027 in the prevention of bleeding during major surgical procedures.
Primary objective* To assess the long-term safety of alirocumab when added to currently available lipid-modifying drug therapy in patients with heterozygous familial hypercholesterolemia (heFH) who have completed one of the following studies:…
The main study aim is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of children (< 16 years) with proven endogenous congenital hyperinsulinism who qualify forsurgery based on response…
To evaluate the efficacy, safety, pharmacology, and patient-reported outcomes of the combination of taselisib plus fulvestrant compared to placebo plus fulvestrant in ER+, HER2- postmenopausal women with locally advanced or MBC and who have had…
Main:Overall survivalSecondary:Time to castration resistant prostate cancer Time to initiation of subsequent antineoplastic therapy Symptomatic skeletal event free survival (SSE-FS) Time to first symptomatic skeletal event (SSE) Time to initiation…
Primary objective: The primary objective is to assess the long-term safety of dupilumab administered in adult patients with AD.Secondary objective:The secondary objective of the study is to assess the immunogenicity of dupilumab in adult patients…
The aim of the present study is to conduct a randomised controlled trial (RCT) to assess the effectiveness of a guided and unguided web based transdiagnostic intervention in treating university and PhD students with depression and/or anxiety.
The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. To gain further insight into clinical effects of AOC3 inhibition on NASH…
To assess short-term and long-term safety and tolerability of gantenerumab (RO4909832) given at doses up to 1200mg subcutaneous (SC) every 4 weeks (Q4W).Secondary Objective of the Open-label extension:- To evaluate of the effect of 1200 mg…
To assess activated microglia in vivo in clinically and/or radiologically active RRMS patients compared to healthy controls using the PET-tracer [11C]SMW139, to assess retest variability in regional [11C]SMW139 brain uptake, and to evaluate which…
The primary objectives of this study is to determine whether uptake of 89Zr CriPec® docetaxel in tumour lesions can be detected and quantified
In this extension study, the long-term safety, tolerability and efficacy of UCB0942 will be studied when used as an adjunctive therapy for partial seizures in adult volunteers with high drug resistant partial epilepsy.
The main trial objectives are to demonstrate a non-flat dose response curve, to evaluate the size of the treatment effect (using the absolute difference in proportions of patients with histological improvement between BI 456906 and placebo at week…
The purpose of this BIVV020 Phase 2 study is to determine the preliminary efficacy, safety, and tolerability of BIVV020 in three CIDP subpopulations including standard of care (SOC)-Treated, SOC-Refractory, and SOC-Naïve.
The trial will investigate the safety and tolerability of BI 685509 in patients with CSPH in compensated cirrhosis due to HBV, HCV and NASH with or without T2DM and the combination of BI 685509 and empagliflozin in patients with CSPH in compensated…
The trial will compare two doses of BI 685509 (2 mg and 3 mg BID) with placebo, on top of standard of care, in patients with CSPH in compensated alcohol-related cirrhosis. The primary objective is to estimate the mean difference between treatment…
Primary objective:- To demonstrate the efficacy of twice-weekly s.c. 1080-mg infusions of pegcetacoplan compared with that of placebo in patients with CAD.Secondary objectives:- To demonstrate the effect of pegcetacoplan on the number of PRBC…
The purpose of this study is to evaluate the safety, pharmacokinetics, and activity of GDC-6036 combined with other anti-cancer therapies in patients with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC) that harbors a…
To evaluate the Long-Term Safety and Efficacy of upadacitinib.
Primary Objective: To assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve CR/CRhSecondary Objectives:To describe response rate, duration of response, event-free…