A Phase III Multicenter Study of Valganciclovir for the Prevention of Late Cytomegalovirus Infection After Allogenic Hematopoietic Stem Cell Transplantation.
This study is a phase III, randomized, double-blind, palacebo-controlled, multicenter study
of the drug valganciclovir. This study is to see if taking prophylactic doses of
valganciclovir starting 100 days after stem cell transplantation can prevent late CMV from
Participants will be randomized (like a flip of a coin) into one of two groups. Neither the
participant nor the doctor will know which group the participant is in. One group will
receive the drug valganciclovir. The other group will receive a pill that looks like
valganciclovir, but does not contain any active medicine (a placebo).
Participants enrolled in the study will take the drug by mouth daily starting at day 100
post stem cell transplant. Participants will also have blood samples taken along with their
routine blood weekly, until day 270. Participants will also be required to return to their
routine clinic visits.
Participants' acquiring an active CMV bloodstream infection at the time of the study will
receive ganciclovir by the vein twice a day or a high dose of valganciclovir. Participants
will be instructed to stop taking the study drug during the treatment time. After active CMV
infection can no longer be detected, the treatment will be stopped. Patients will start
taking the study drug and will be monitored for a CMV bloodstream infection until 270 days
after transplant. Participants developing symptoms that look like CMV disease (pneumonia,
infection of the intestines, eye infection) while on the study drug, will have an
examination and lab tests to diagnose the organism. Participants that are hospitalized for
CMV disease or for any other reason are asked to notify study personnel.
Participants will need to record study medicine taken in a daily study drug diary.
Questionnaires will be filled out by the participant throughout the study, they will also be
called monthly to see how they are doing and feeling overall.
After 270 days, participants will complete the study drug phrase. They will receive follow
up phone calls on days 400, 520, and 640 days after transplant to see how they are doing.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Mark R. Litzow, M.D.
United States: Food and Drug Administration
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