Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients

Liver Transplantation Clinical Trial

Official title:

Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients: A Single Center Experience With Oral Ganciclovir Versus Valganciclovir

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00364052
• Other study ID #: VAL109
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 11, 2006
• Last updated: August 16, 2006
• Start date: August 2006
• Est. completion date: January 2007

Study information

• Verified date: August 2006
• Source: Oregon Health and Science University
• Contact: Ali J Olyaei, PharmD
• Phone: 503-494-8132
• Email: olyaeia[@]ohsu.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• oral Valganciclovir vs oral Ganciclovir

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University