NCT00364052

Brief Summary

Null Hypothesis: There is no significant difference in the incidence of CMV infection when using oral valganciclovir or ganciclovir as prophylactic anti-viral therapy. Alternate Hypothesis: There exists a significant difference in the incidence of CMV infection when oral valganciclovir is used for CMV prophylaxis rather than oral ganciclovir. A formal hypothesis to be tested should be defined.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2006

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

August 17, 2006

Status Verified

August 1, 2006

First QC Date

August 11, 2006

Last Update Submit

August 16, 2006

Conditions

Liver Transplantation

Keywords

Valganciclovir, Oral Ganciclovir, Liver transplant

Interventions

oral Valganciclovir vs oral GanciclovirDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All liver transplants will be performed at Oregon Health \& Science University (OHSU) and the OHSU surgical and medical staff will treat patients.

You may not qualify if:

  • Portland Veterans Affairs Medical Center liver transplant recipients
  • Patients deceased within thirty days of receiving liver allograft
  • Patients with low risk of acquiring CMV infection: donor-negative and recipient-negative (D-/R-)
  • Patients undergoing re-transplantation
  • Lost to follow-up (minimum follow-up is 1 year)
  • History of CMV infection or disease
  • Anti-CMV therapy within the past 30 d
  • Severe, uncontrolled diarrhea or evidence of malabsorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ali J Olyaei, PharmD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali J Olyaei, PharmD

CONTACT

503-494-8132olyaeia@ohsu.edu

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Study Completion

January 1, 2007

Last Updated

August 17, 2006

Record last verified: 2006-08