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Clinical Trial Summary

The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.


Clinical Trial Description

This is a Phase 2, randomized, double-blind, placebo-controlled study of NPC-21 for kidney transplant recipients at high risk of CMV infection in the United States and Japan. Approximately 108 eligible patients will be randomized prior to first study drug administration to receive low-dose NPC 21, high-dose NPC-21, or placebo. Randomization will be stratified by region (United States or Japan) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04225923
Study type Interventional
Source Nobelpharma
Contact
Status Completed
Phase Phase 2
Start date June 1, 2020
Completion date February 8, 2023

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