19 results
To evaluate the use of concentration-controlled everolimus, with the reduction or the elimination of tacrolimus, to provide superior renal function and to provide non-inferior rates of the composite efficacy endpoint compared to the tacrolimus…
The main objective is to find out if dividing the daily oral dose prevents diarrhea without increasing risk of graft failure. Secondary objective is the quality of life and effect on intestinal permeability.
The overall objective of this feasibility study is to investigate the usefulness of sustained release dexamphetamine in the treatment of cocaine dependence, and * dependent upon the results of both this study and the parallel studies of topiramate…
To decrease the cumulative incidence of (hematological) relapse
The main objective of the study is to demonstrate the utility and safetyof the IFN-γ ELISPOT marker for the stratification of kidney transplantrecipients into low and high IS regimens. The enrichment study will testnon-inferiority of low IS regimen…
The aim of this study is to compare the effectiveness of TAC with MMF as a second line treatment for AIH. Proportion of patients with CR after 12 months of treatment will be the primary outcome parameter to determine effectivity.
Primary:To demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks compared to remaining on ABC/DTG/3TC (or DTG and an approved dual-NRTI scheme) over 48 weeks.Secondary:To…
Primary objective:Evaulation of safety and tolerability of niraparibExploratory:Evaluation of the efficacy of niraparib relative to placebo as measured by disease-free survival (DFS)Evaluation of distant recurrence-free survival (DRFS)Time to first…
Main objective of the trial is to determine the effect of individualizing the immunosuppressive therapy based on baseline immune-risk stratification according to 2 new biomarkers (d-sp ELISPOT IFN-γ and donor/recipient HLA Eplet Mismatch), in a…
Objective(s)* To investigate the pharmacokinetic behaviour of a single dose of MMF;o Plasma concentrationso Cellular concentrationso Relationship between plasma and cellular concentrations* To investigate the pharmacodynamic effects of a single dose…
The primary objective of the main non-inferiority study is to determine the safety of TACmono starting nine months after kidney transplantation in immunologically low-risk patients in terms of BPAR-rate 15 months after transplantation compared to…
Primary objective:- To assess the efficacy of niraparib in subjects with measurable mCRPC and who have either biallelic DNA-repair anomalies in BRCA (BRCA 1 and BRCA 2 or germline BRCA. Secondary objectives:- To assess the efficacy of niraparib in…
Objectives: The primary objectives of this study are: • Part 1 (dose-escalation): To evaluate the safety of SYD985 in combination with niraparib to determine the maximum tolerated dose (MTD) and recommended combination dose regimen for expansion (…
Primary Objectives:- To determine the BE of a RS FDC tablet formulation of niraparib and Abiraterone Acetate with respect to niraparib and Abiraterone Acetate co-administered as single agents at steady state under modified fasted conditions in…
• To characterize the systemic response to mucosal immunization with an oral cholera vaccination challenge.• To characterize the local response to intranasal rechallenge after cholera vaccination as outcome measure for nasal mucosal immunity.• To…
The primary objective of this study is to determine the immune-activating capacity of treatment with pembrolizumab and carboplatin/paclitaxel in the neo-adjuvant setting of primary stage IV ovarian cancer as measured by the alteration in magnitude…
Dual Primary Objectives:• To compare progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) of niraparib plus pembrolizumab versus placebo…
Primary Objective• To compare the progression free survival (PFS) of programmed death-ligand 1 (PD-L1) positive patients with Stage III or IV high-grade nonmucinous epithelial ovarian cancer treated with platinum-based combination therapy,…
The purpose of this study is to understand if a new treatment for prostate cancer (niraparib) added to a standard treatment (abiraterone acetate plus prednisone) will work better than the standard treatment alone.Cohort 3: the purpose is to evaluate…