A Phase 2 Study Evaluating The Safety And Efficacy Of A Human Immunoglobulin Monoclonal Antibody That Targets The Hcmv Glycoprotein B In Cmv Negative Recipients (R-) Receiving Their First Solid Organ Transplant From Cmv Positive Donors (D+)
Posted Date: Mar 29, 2021
- Investigator: Rita Alloway
- Type of Study: Drug
This Phase 2 clinical research study will assess the efficacy and safety of the study drug NPC-21, to prevent clinically significant CMV infection after kidney transplantation. NPC 21 is a fully human monoclonal antibody that is designed to target a receptor on the CMV virus thus blocking the spread of CMV. NPC-21 or placebo will be administered approximately 60 minutes via IV infusion on Day 1, Weeks 4, 8, and 12. After the patient develops detectable CMV disease or CMV viremia, they can receive standard of care for CMV treatment. Adult, CMV negative, kidney transplant patients must by <100kg and be receiving a CMV positive donor.
Recipient Of A Cmv Negative Kidney Transplant From A Cmv Positive Kidney Donor
Kidney Transplant, Cytomegalovirus, Antibody
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