Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in Liver Transplant Recipients
Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Disease
Intervention: Preemptive Therapy (Other); Prophylaxis with Valganciclovir (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s): Nina Singh, MD, Principal Investigator, Affiliation: University of Pittsburgh
Summary
This is a study of two different approaches for the prevention of CMV disease in liver
transplant recipients. The primary purpose is to determine if Preemptive therapy is the same
or better than Prophylaxis therapy for the prevention of CMV disease in CMV seronegative
recipients that receive a CMV positive liver transplant. Patients meeting study criteria and
who have provided informed consent will be randomized within 10 days of transplant to
receive in an open label design, either antiviral prophylaxis with valganciclovir 900 mg
orally once daily for 100 days or preemptive therapy (weekly monitoring for asymptomatic CMV
viremia by plasma PCR) for 100 days with initiation of oral valganciclovir 900mg orally
twice daily only at onset of CMV viremia and continued until plasma PCR is negative on two
consecutive weekly PCR tests.
Clinical Details
Official title: Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in High-Risk R-D+ Liver Transplant Recipients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Incidence of CMV disease
Secondary outcome: All cause mortality
Detailed description:
Title: Prophylaxis versus Preemptive Therapy for Prevention of CMV in High-Risk R-/D+ Liver
Transplant Recipients ['CAPSIL' Study]
Population: CMV seronegative recipients (18 years of age or older) of a liver transplant
from a CMV seropositive donor (R-/D+)
Phase: IV
Number of Clinical Sites: 5
Study Duration: 5 years
Subject Participation Duration: Until the closure of the study and not to exceed 5 years
from enrollment.
Description of Agent or Intervention: Oral Valganciclovir hydrochloride:
2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]-3-hydroxypropyl
(2S)-2-amino-3-methylbutanoate. Currently marketed as Valcyte ®.
The primary objective is to compare prophylaxis versus preemptive therapy using
valganciclovir for the prevention of CMV disease in R-/D+ liver transplant recipients
Secondary objectives :To assess the two preventive strategies for:
- Clinical outcomes (major bacterial, fungal and non-CMV viral infections, rejection,
graft loss and mortality)
- Hematologic toxicity (assessment of neutropenia and receipt of hematopoietic growth
factor during study days 1-107)
Study Design: This is a prospective, randomized, multicenter trial of preemptive therapy vs.
prophylaxis for prevention of CMV disease in R-D+ liver transplant patients. Patients
meeting study criteria and who have provided informed consent will be randomized within 10
days of transplant to receive in an open label design, either antiviral prophylaxis with
valganciclovir 900 mg orally once daily or preemptive therapy (weekly monitoring for CMV
viremia by plasma PCR) for 100 days post- randomization with initiation of oral
valganciclovir 900mg orally twice daily at onset of CMV viremia and continued until plasma
PCR is negative on two consecutive weekly PCR tests). Valganciclovir dosages will be
adjusted for renal dysfunction. Study participants will be followed during the intervention
period (100 days post randomization) and until 12 months post-transplant for CMV disease,
toxicity, and clinical outcomes (opportunistic infections, rejection, graft loss and
mortality).
Estimated Time to Complete Enrollment: Approximately 3. 5 years
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Greater than 18 yrs of age
- Negative CMV serology recipient
- Positive CMV serology donor
- Liver transplant within 10 days
- Absolute neutrophil count>1000
- Female subjects of childbearing potential must have negative pregnancy test and agree
to use effective contraception during and for 3 months after receipt of
valganciclovir
- Male subjects, that have not had a vasectomy, must agree to practice barrier method
of contraception during and for 3 months after receipt of valganciclovir
Exclusion Criteria:
- Enrollment in other investigational drug trials
- Hypersensitivity to acyclovir, ganciclovir or valganciclovir
- Breast feeding mother
- HIV infection
- Multiple organ transplant or re-transplantation
- Life expectancy of less than 72 hours
Locations and Contacts
UCLA, Los Angeles, California 90095, United States; Recruiting Drew Winston, MD, Phone: 310-825-6264, Email: dwinston@mednet.ucla.edu Janet Moooney, Phone: 310-794-8600, Email: JMooney@mednet.ucla.edu Drew Winston, MD, Principal Investigator
Emory Health care, Atlanta, Georgia 30322, United States; Recruiting G M Lyon, MD, Phone: 404-712-2051, Email: Marshall.Lyon@emoryhealthcare.org Marti Sears, Phone: 404-712-5411, Email: mhsears@emory.edu G. Marshall Lyon, MD, Principal Investigator
Mayo Clinic Transplant Center, Rochester, Minnesota 55902, United States; Recruiting Raymund Razonable, MD, Phone: 507-284-3747, Email: razonable.raymund@mayo.edu Kristen Cornwell, Phone: 507-266-8493, Email: Cornwell.kristen@mayo.edu Raymund Razonable, MD, Principal Investigator
Mount Sinai Hospital, New York, New York 10029, United States; Recruiting Shirish Huprikar, MD, Phone: 212-241-6885, Email: shirish.huprikar@mssm.edu Thomas Schiano, MD, Phone: 212-659-8502, Email: thomas.schiano@mountsinai.org Shirish Huprikar, MD, Principal Investigator Thomas Schiano, MD, Sub-Investigator
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States; Recruiting Fernanda P Silveira, MD, Phone: 412-648-6512, Email: Silveirafd@upmc.edu Fernanda P Silveira, MD, Principal Investigator
University of Washington, Seattle, Washington 98195, United States; Recruiting Ajit Limaye, MD, Phone: 206-598-6131, Email: Limaye@u.washington.edu Michaela Kusumi, BS, Phone: 206-598-1810 Ajit Limaye, MD, Principal Investigator
Additional Information
Starting date: October 2012
Last updated: December 4, 2014
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