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Completed Phase 4 Interventional Results available

CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")

ClinicalTrials.gov ID: NCT01552369

Public ClinicalTrials.gov record NCT01552369. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 19, 2026, 3:20 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in High-Risk R-D+ Liver Transplant Recipients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a trial of preemptive therapy vs. prophylaxis for prevention of Cytomegalovirus (CMV) disease in R-D+ liver transplant patients. Subjects 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). A minimum of 176 subjects will be enrolled in the study. The study duration is 7 years. The primary objective of this study is to compare prophylaxis versus preemptive therapy using valganciclovir for the prevention of CMV disease in R-/D+ liver transplant recipients.

Study identification

NCT ID
NCT01552369
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
205 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 28, 2012
Primary completion
Jun 21, 2018
Completion
Jun 21, 2018
Last update posted
Aug 25, 2021

2012 – 2018

United States locations

U.S. sites
6
U.S. states
6
U.S. cities
6
Facility City State ZIP Site status
Ronald Reagan University of California Los Angeles Medical Center Los Angeles California 90095-8358
Emory Clinic - Transplant Center Atlanta Georgia 30322-1013
Mayo Clinic, Rochester - Infectious Diseases Rochester Minnesota 55905-0001
Mount Sinai School of Medicine - Medicine - Infectious Diseases New York New York 10029-6504
University of Pittsburgh - Medicine - Infectious Diseases Pittsburgh Pennsylvania 15213-3403
University of Washington - Medicine Seattle Washington 98195-7110

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01552369, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 25, 2021 · Synced Sep 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01552369 live on ClinicalTrials.gov.

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