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Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in Liver Transplant Recipients (CAPSIL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Nina Singh, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01552369
First received: March 2, 2012
Last updated: June 16, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Cytomegalovirus Disease Other: Preemptive Therapy Drug: Prophylaxis with Valganciclovir Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in High-Risk R-D+ Liver Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Nina Singh, University of Pittsburgh:

Primary Outcome Measures:
  • Incidence of CMV disease [ Time Frame: One year post enrollment ]
    All cases of CMV disease identified during 1 year follow up


Secondary Outcome Measures:
  • All cause mortality [ Time Frame: One year post enrollment ]
    All deaths occurring within one year


Other Outcome Measures:
  • Incidence of late onset CMV diseae [ Time Frame: After 100 days post-randomization to 1 year ]
    CMV disease occurring after completion of prophylaxis or monitored CMV viremia testing

  • Incidence of allograft rejection [ Time Frame: Randomization to 1 year ]
    Cases of allograft rejection identified by biopsy. When biopsy not available, cases identified clinically that require pharmaceutical intervention will also be counted.

  • Incidence of graft loss [ Time Frame: Randomization to 1 year ]
    All cases in which the graft is replaced for poor function

  • Incidence of neutropenia [ Time Frame: Randomization to 107 days post-enrollment ]
    Absolute neutrophil count <1000


Estimated Enrollment: 180
Study Start Date: October 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prophylaxis with Valganciclovir
Subjects given 900mg valganciclovir daily for 100 days post transplantation.
Drug: Prophylaxis with Valganciclovir
All subjects in this arm are given 900mg valganciclovir daily for 100 days post transplantation. Dosage may be adjusted for renal dysfunction
Experimental: Preemptive Therapy [PET]
Subjects monitored with weekly CMV PCR testing and given 900 mg valganciclovir twice daily only if PCR is positive. Therapy is stopped after 2nd negative PCR test
Other: Preemptive Therapy
Subjects monitored for CMV viremia with weekly CMV PCR testing. 900 mg of Valganciclovir given twice daily only after a positive CMV PCR test and stopped after PCR is negative for 2 weeks. Dosages may be adjusted for renal dysfunction

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: 7 years

Subject Participation Duration: Until the closure of the study and not to exceed 7 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 5.0 years

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552369

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
United States, Georgia
Emory Health care
Atlanta, Georgia, United States, 30322
United States, Minnesota
Mayo Clinic Transplant Center
Rochester, Minnesota, United States, 55902
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
Investigators
Principal Investigator: Nina Singh, MD University of Pittsburgh
  More Information

Responsible Party: Nina Singh, Professor of Medicine, Transplant Infectious Diseases, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01552369     History of Changes
Other Study ID Numbers: DMID 11-0073
272201100041C-3-0-1 ( U.S. NIH Grant/Contract )
Study First Received: March 2, 2012
Last Updated: June 16, 2017

Keywords provided by Nina Singh, University of Pittsburgh:
liver transplantation
CMV disease
valgancyclovir
prophylaxis
preemptive therapy

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 16, 2017