Clinical Trials Logo

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

See also
  Status Clinical Trial Phase
Terminated NCT02439957 - A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Phase 3
Terminated NCT02439970 - A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease Phase 3
Active, not recruiting NCT04904614 - Letermovir Use in Heart Transplant Recipients Phase 4
Completed NCT01573039 - Cut Off for the Diagnosis of Cytomegalovirus (CMV) Disease in Serum-positive Kidney Transplant Recipients N/A
Completed NCT01509404 - Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection Phase 4
Completed NCT00907686 - TT-CMV Observational Birth Cohort Study N/A
Completed NCT04129398 - MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042) Phase 3
Recruiting NCT00828503 - Certican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients Phase 2