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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

Page last updated: August 23, 2015

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