24 results
To measure the efficacy (change in systolic blood pressure and LDL cholesterol) and tolerability of a polypill in individuals with raised risk of a cardiovascular event.
The primary objective of this study is to measure whether αvβ3 integrin expression and tracer uptake values of 68Ga-DOTA-(RGD)2 change in patients with (recurrent) low-flow vascular malformations after embolization therapy.
PrimaryTo determine whether the palatability of a newly developed formulation of valacyclovir is non-inferior to administration of crushed and suspended tablets in children, is the primary objective of the second phase of the trial.The primary…
Evaluation of intensive therapy for relapsed B-cell lymphoma with CNS localisation. Treatment includes:a. intrathecal administration of rituximab, B. combining R-DHAP with high dose methotrexate intravenously.The following endpoints will be…
Primary objective• To assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin following intravenous (IV) administrationSecondary objectives• To assess the safety of eribulin when co-…
Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this phase III study is to compare treatment with bortezomib/dexamethasone + panobinostat to bortezomib/dexamethasone +…
This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability and pharmacokinetics of midostaurin in children <18 years of age and >= 3 months who have relapsed or refractory leukemias that may benefit…
In this study we want to evaluate the safety and efficacy of the new drug ZPL389. ZPL389 is tested in various strengths in patients with moderate or severe atopic dermatitis. The effects of ZPL389 are compared with those of a placebo.
To assess the efficacy and safety of LCI699 in CD patients
The aim of this study is to assess differences in tumour microenvironment between HPV+ and HPV- oropharyngeal HNSCC using [68Ga]Ga-RGD2 PET/CT and perfusion CT.
Primary: To characterize safety and tolerability of TNO155 and identify a recommended dose and regimen for future studies in adult patients with advanced solid tumors. And a recommended dose of TNO155 in combination with nazartinib in patients with…
The primary objective of this study is to determine the feasibility and safety of quantitative fluorescence endoscopy using the fluorescent tracer durvalumab-680LT to get insight in the PD-L1 expression before and after neoadjuvant therapy in…
1.1 Primary study objectives To investigate the safety, tolerability and biochemical effects of 225Ac-PSMA injected in patients with metastatic prostate cancer. Primary objective:- To assess the safety and tolerability of 225Ac-PSMA administered…
All primary and secondary objectives will compare zanubrutinib (also known as BGB-3111) plus rituximab followed by zanubrutinib monotherapy versus bendamustine plus rituximab followed by observation only.Primary:• To compare efficacy, as measured by…
Primary objectivePrimary population (former smokers cohort):- Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD.Secondary…
Primary objective:-To confirm that the Event-Free Survival (EFS) in patients >= 3 years of age with WHO grade IV/CNS WHO grade 4 and WHO grade III/CNS WHOgrade 3 diffuse high grade gliomas as well as diffuse high grade gliomas without a…
The primary objective is to demonstrate the efficacy of Peptide Receptor Radionuclide Therapy with 177Lu-edotreotide to prolong progression freesurvival in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine…
The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or high-risk TIA when given in addition to standard…
Primary objectives: Part A: Generate an airway gene expression signature for itepekimab treatment using RNA sequencing in former smokers with COPDPart B: Validate the airway gene expression signature from Part A in former smokers with COPD in Part…
Primary: To assess best overall response rate (ORR) up to 8 cycles. Secondary: ORR, complete response (CR), very good partial response (VGPR), progression free survival (PFS), overall survival (OS), safety, PK, exposure-response (efficacy and safety…