Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients

• Conditions: Liver Transplantation

• Registration Number: NCT00364052
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

The objective for this retrospective clinical study is to describe the incidence of CMV infection in orthoptic liver transplant recipients who receive oral valganciclovir or ganciclovir as their CMV prophylactic anti-viral therapy.

Endpoints:

Primary Endpoint

CMV infection will be characterized as viremia, syndrome or disease by the abovementioned methods for up to one year post-transplantation.

Secondary Endpoints

1. Patient and allograft survival based on donor/recipient CMV status

2. Incidence of graft rejection and loss associated with CMV infection

3. Time to hepatitis C virus (HCV) occurrence

4. Incidence of HSV, EBV and VZV reactivations

5. Severity of HCV occurrence based on biopsy reports based on the Knodell score

6. Safety and tolerability of oral valganciclovir and ganciclovir

Study Timeline

• Status Verified: 2006-08
• Study Start: 2006-08
• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Last Update Submitted: 2006-08-16
• Last Update Posted: 2006-08-17
• Study Completion: 2007-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified