5 results
In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antiemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed CINV induced by non-AC based…
Primary Objectives:*Phase 0: To determine the receptor occupancy of OPN-305 1.5mg/kg in patients receiving an ECD, DCD or SCD(CIT>18h) kidney transplantation and to verify the doses of OPN-305 to be used in Part A of the study.*Part A: to…
Primary: To investigate the pharmacokinetics of palonosetron in plasma from three different sizes of HP-3020 transdermal patch applied for 24 hours as compared to intravenous palonosetron (Cohort 1) and to investigate the pharmacokinetics of…
The objective of the Simbici project is to evaluate the effect of bilateral cochlear implantation compared to unilateral cochlear implantation in children, in the domains of primary auditive capacities, language development and social-emotional…
To assess out to one-year the clinical status of patients who completed the double-blind part B of the 6-month study period in the Opsona phase II protocol (OPN305-102) by recording the following:• Incidence of biopsy-proven allograft rejection or…