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NCT01552369 · ClinicalTrials.gov registry record · Phase 4
CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 205
- Enrollment target
NCT01552369 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 205 participants.
The verdict
NCT01552369, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 205 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Valganciclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2012-10-29 |
| Est. Completion | 2018-06-22 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01552369
The ClinicalTrials.gov registry entry for NCT01552369 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Valganciclovir is the first listed.
NCT01552369 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01552369 about?
NCT01552369 is a clinical study titled "CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")". 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 d...
What is the current status of trial NCT01552369?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 205 participants. The study started on 2012-10-29. Estimated completion is 2018-06-22.
What interventions are being tested in trial NCT01552369?
The interventions under investigation include: Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT01552369?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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