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Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by Oregon Health and Science University.
Recruitment status was:  Not yet recruiting
Information provided by:
Oregon Health and Science University Identifier:
First received: August 11, 2006
Last updated: August 16, 2006
Last verified: August 2006

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.

Condition Intervention Phase
Liver Transplantation
Drug: oral Valganciclovir vs oral Ganciclovir
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
Official Title: Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients: A Single Center Experience With Oral Ganciclovir Versus Valganciclovir

Resource links provided by NLM:

Further study details as provided by Oregon Health and Science University:

Estimated Enrollment: 200
Study Start Date: August 2006
Estimated Study Completion Date: January 2007
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.


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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00364052

Contact: Ali J Olyaei, PharmD 503-494-8132

Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: Ali J Olyaei, PharmD Oregon Health and Science University
  More Information Identifier: NCT00364052     History of Changes
Other Study ID Numbers: VAL109
Study First Received: August 11, 2006
Last Updated: August 16, 2006

Keywords provided by Oregon Health and Science University:
Valganciclovir, Oral Ganciclovir, Liver transplant

Additional relevant MeSH terms:
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017