There are about 13446 clinical studies being (or have been) conducted in Belgium. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Renal excretion is a minor elimination route of telotristat etiprate. So this trial is intended to assess the drug behaviour in subjects with decreased renal function. This is a staged study with Part B contingent upon the results of Part A. Part A will enrol a total of 16 subjects, eight with severely impaired renal function and eight healthy subjects. Part B with enrol a total of 16 subjects, eight subjects in each additional renal function group, i.e. mildly impaired renal function group and moderately impaired group.
The main purpose of this study is to evaluate the effect of intravenous (IV) infusions of piperacillin/tazobactam on the pharmacokinetics (PK) of JNJ-63549109 after a single oral dose of lumicitabine in healthy adult participants.
There is a clear need for a novel method that can readily assess gastric motility in daily clinical practice. Isometric determination of the stomach motility would avoid the use of a large flaccid balloon while still being affordable. The aim of this study was to determine the optimal balloon characteristics that enable to measure motility-induced pressure changes in healthy volunteers.
Brief Summary: This Phase IIb study is a randomized, double-blind, parallel group, placebo and active-controlled study to evaluate the efficacy, safety, PD, and population PK of vamorolone administered orally at daily doses of 2.0 mg/kg and 6.0 mg/kg versus prednisone 0.75 mg/kg/day and placebo over a Treatment Period of 24 weeks, and to evaluate persistence of effect over a Treatment Period of 48 weeks in ambulant boys ages 4 to <7 years with DMD.
WP2.1. PK/PD target attainment Plasma exposure ELF exposure WP2.2. Predictive dosing algorithm WP2.3. ECMO subset
A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.
The purpose of this study is to measure the blocking of [18F]-JNJ-64413739 uptake in the brain at the time to reach maximum plasma concentration (Tmax) and at 24 hours postdose of JNJ-55308942 following a single dose of JNJ-55308942; and to model the exposure/receptor interaction of JNJ-55308942.
In the POWDER 1 study, paroxysmal atrial fibrillation (AF) patients undergoing conventional contact force (CF)-guided PVI were investigated. Patients were randomized between continuing previously ineffective antiarrhythmic drug therapy (ADT) or stopping ADT at the end of the blanking period. This trial, showed an added value of ADT after ablation (in support of 'hybrid rhythm control' as an alternative treatment strategy for AF in some patients). In the POWDER 2 trial, an analogue study in persistent AF patients will be performed. All patients will undergo ablation index (AI)- and IL distance (ILD)-guided PVI (just like in VISTAX trial) and continue previously ineffective ADT during the blanking period. 'PVI only' was chosen as the ablation strategy according to the STAR AF trial findings.
This clinical study was designed to evaluate the pharmacokinetics, safety and efficacy of ligelizumab in children from 12 to < 18 years of age, with chronic spontaneous urticaria (CSU). The participants were treated with ligelizumab as an add-on therapy to approved doses of H1 antihistamines (H1AH) following the guideline on treatment of CSU.
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.