Liver TransplantationNCT00364052
Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients
An observational study of Liver Transplantation, run by Oregon Health and Science University.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- oral Valganciclovir vs oral Ganciclovir
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All liver transplants will be performed at Oregon Health \& Science University (OHSU) and the OHSU surgical and medical staff will treat patients.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients: A Single Center Experience With Oral Ganciclovir Versus Valganciclovir
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.
Read the 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
- 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
- Conditions
- Liver Transplantation
- Being tested
- oral Valganciclovir vs oral Ganciclovir
- Keywords
- Valganciclovir, Oral Ganciclovir, Liver transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral Valganciclovir vs oral GanciclovirDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startAug 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Investigators
- Ali J Olyaei, PharmD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364052
- Sponsor's protocol ID
- VAL109
- Status last verified
- Aug 2006
- First submitted
- 11 Aug 2006
- Last updated
- 17 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients: A Single Center Experience With Oral Ganciclovir Versus Valganciclovir
- ClinicalTrials.gov ID
- NCT00364052
- Acronym / sponsor ID
- VAL109
- Conditions
- Liver Transplantation
- Keywords
- Valganciclovir, Oral Ganciclovir, Liver transplant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Jan 2007
- First posted
- 15 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All liver transplants will be performed at Oregon Health \& Science University (OHSU) and the OHSU surgical and medical staff will treat patients.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral Valganciclovir vs oral Ganciclovir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali J Olyaei, PharmD principal investigator
Oregon Health and Science University
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali J Olyaei, PharmD (503-494-8132, olyaeia@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2006.