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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00364052
First Posted: August 15, 2006
Last Update Posted: August 17, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oregon Health and Science University
  Purpose

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.

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364052


Contacts
Contact: Ali J Olyaei, PharmD 503-494-8132 olyaeia@ohsu.edu

Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Ali J Olyaei, PharmD Oregon Health and Science University
  More Information

ClinicalTrials.gov Identifier: NCT00364052     History of Changes
Other Study ID Numbers: VAL109
First Submitted: August 11, 2006
First Posted: August 15, 2006
Last Update Posted: August 17, 2006
Last Verified: August 2006

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

Additional relevant MeSH terms:
Ganciclovir
Valganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action