Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients
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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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | January 2007 |
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
- Patient and allograft survival based on donor/recipient CMV status
- Incidence of graft rejection and loss associated with CMV infection
- Time to hepatitis C virus (HCV) occurrence
- Incidence of HSV, EBV and VZV reactivations
- Severity of HCV occurrence based on biopsy reports based on the Knodell score
- Safety and tolerability of oral valganciclovir and ganciclovir
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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| Contact: Ali J Olyaei, PharmD | 503-494-8132 | olyaeia@ohsu.edu |
| Principal Investigator: | Ali J Olyaei, PharmD | Oregon Health and Science University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00364052 History of Changes |
| Other Study ID Numbers: | VAL109 |
| Study First Received: | August 11, 2006 |
| Last Updated: | August 16, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Oregon Health and Science University:
|
Valganciclovir, Oral Ganciclovir, Liver transplant |
Additional relevant MeSH terms:
|
Ganciclovir Valganciclovir Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013