Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.

See also
Status	Clinical Trial	Phase
Completed	`NCT00225394` - Long Term Use of Valganciclovir for Prophylaxis of CMV Disease in Kidney and Pancreas Transplant Patients	Phase 4
Withdrawn	`NCT00159055` - Adoptive Immunotherapy for CMV Disease	Phase 1/Phase 2
No longer available	`NCT03010332` - Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease

NCT number	NCT03443869
Study type	Interventional
Source	Merck Sharp & Dohme LLC
Contact
Status	Completed
Phase	Phase 3
Start date	May 3, 2018
Completion date	April 5, 2022

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms