6 results
Primary:The primary objective is to determine the safety and tolerability of the combination treatment, i.e. GCb, VPA and GCV, by evaluation of adverse events (AE*s) serious adverse events (SAE*s) and all clinically significant changes in clinical…
Primary Objective: Investigate whether early valganciclovir treatment of children with SNHL of >= 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent deterioration of the hearing loss at 1 year follow-up.…
Primary Objective: Investigate whether early valganciclovir treatment of children with SNHL of * 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent deterioration of the hearing loss at follow-up (age 18 * 22 months…
The purpose of the study is to investigate how quickly and to what extent cenerimod is absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics).
The objectives of the study are as follows:Primary:• Part 1: To assess the pharmacokinetics and relative bioavailability of three different formulations of PA101 (4% cromolyn sodium with and without mannitol, and 6% cromolyn sodium without mannitol…
Primary:* To determine the efficacy profile of PA101 delivered via a high efficiency nebulizer (eFlow®,PARI) in comparison with placebo following 6 weeks of treatment in patients with indolentsystemic mastocytosis (ISM) who are symptomatic despite…