Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in Liver Transplant Recipients (CAPSIL)
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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 [CMV] Disease |
Other: Preemptive Therapy Drug: Prophylaxis with Valganciclovir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in High-Risk R-D+ Liver Transplant Recipients |
- Incidence of CMV disease [ Time Frame: One year post enrollment ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: One year post enrollment ] [ Designated as safety issue: No ]
- Incidence of late onset CMV diseae [ Time Frame: After 100 days post-randomization to 1 year ] [ Designated as safety issue: No ]CMV disease occurring after completion of prophylaxis or monitored CMV viremia testing
- Incidence of allograft rejection [ Time Frame: Randomization to 1 year ] [ Designated as safety issue: No ]
- Incidence of graft loss [ Time Frame: Randomization to 1 year ] [ Designated as safety issue: No ]
- Incidence of neutropenia [ Time Frame: Randomization to 107 days post-enrollment ] [ Designated as safety issue: Yes ]Absolute neutrophil count <1000
| Estimated Enrollment: | 180 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | November 2016 |
| Estimated Primary Completion Date: | May 2016 (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: 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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- Renal dysfunction [Creatinine clearance <10ml/min or require dialysis]
- 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| United States, California | |
| UCLA | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Drew Winston, MD 310-825-6264 dwinston@mednet.ucla.edu | |
| Contact: Janet Moooney 310-794-8600 JMooney@mednet.ucla.edu | |
| Principal Investigator: Drew Winston, MD | |
| United States, Georgia | |
| Emory Health care | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: G M Lyon, MD 404-712-2051 Marshall.Lyon@emoryhealthcare.org | |
| Contact: Marti Sears 404-712-5411 mhsears@emory.edu | |
| Principal Investigator: G. Marshall Lyon, MD | |
| United States, Minnesota | |
| Mayo Clinic Transplant Center | Recruiting |
| Rochester, Minnesota, United States, 55902 | |
| Contact: Raymund Razonable, MD 507-284-3747 razonable.raymund@mayo.edu | |
| Contact: Kristen Cornwell 507-266-8493 Cornwell.kristen@mayo.edu | |
| Principal Investigator: Raymund Razonable, MD | |
| United States, New York | |
| Mount Sinai Hospital | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Shirish Huprikar, MD 212-241-6885 shirish.huprikar@mssm.edu | |
| Contact: Thomas Schiano, MD 212-659-8502 thomas.schiano@mountsinai.org | |
| Principal Investigator: Shirish Huprikar, MD | |
| Sub-Investigator: Thomas Schiano, MD | |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98195 | |
| Contact: Ajit Limaye, MD 206-598-6131 Limaye@u.washington.edu | |
| Contact: Saray W Johnson 206-598-1810 Sarahwi@u.washington.edu | |
| Principal Investigator: Ajit Limaye, MD | |
| Principal Investigator: | Nina Singh, MD | University of Pittsburgh |
More Information
No publications provided
| 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 |
| Study First Received: | March 2, 2012 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration United States: Data and Safety Monitoring Board |
Keywords provided by University of Pittsburgh:
|
liver transplantation CMV disease valgancyclovir prophylaxis preemptive therapy |
Additional relevant MeSH terms:
|
Valganciclovir Ganciclovir Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013