MedDataX Logo

The Study is Being Done to See if Taking the Drug Valganciclovir Can Prevent CMV Infection.

NCT ID: NCT00275665

Last Updated: 2011-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is being done in stem cell transplant recipients to see if taking the drug valganciclovir can prevent or reduce serious cytomegalovirus (CMV) infections that can occur 100 days or later after transplant.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 occurring.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Marrow Stem Cell Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Valganciclovir

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Participants who are undergoing allogeneic peripheral blood stem cell, cord blood, or marrow transplantation that are 18 years of age or older, may be eligible to participate in this study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role collaborator

City of Hope National Medical Center

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark R. Litzow, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2124-01

Identifier Type: -

Identifier Source: org_study_id