NCT00275665

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

December 19, 2011

Status Verified

December 1, 2011

Enrollment Period

5.7 years

First QC Date

January 10, 2006

Last Update Submit

December 16, 2011

Conditions

Bone Marrow Stem Cell Transplant

Outcome Measures

Primary Outcomes (2)

  • CMV disease

  • Invasive bacterial and fungal infections

Secondary Outcomes (5)

  • The occurrence of CMV infection or the occurrence of CMV disease (whichever occurs first) between enrollment and day 270 after transplantation.

  • Occurrence of CMV disease between randomization and day 270

  • The occurrence of other documented clinically significant human herpesvirus infections after randomization and day 270.

  • Survival to include a comparison of treatments at day 270 and day 640

  • Safety-comparison of adverse events and serious adverse events that occur on the two arms during the study

Interventions

ValganciclovirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Valganciclovir

Intervention Hierarchy (Ancestors)

GanciclovirAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mark R. Litzow, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

November 1, 2001

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

December 19, 2011

Record last verified: 2011-12

Locations

US(1)