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NCT01509404 · ClinicalTrials.gov registry record · Phase 4
Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection
A Phase 4 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT01509404: Completed Phase 4 study, sponsored by Medical University of South Carolina.
NCT01509404 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01509404, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.
Primary Outcome
Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant
Interventions
- DRUG Valganciclovir
- BIOLOGICAL CMV hyperimmune globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
What the finished NCT01509404 record still lists
NCT01509404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Valganciclovir is the first listed.
NCT01509404 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01509404 about?
NCT01509404 is a clinical study titled "Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection". The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for p...
What is the current status of trial NCT01509404?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2011-11. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01509404?
The interventions under investigation include: Valganciclovir (DRUG), CMV hyperimmune globulin (BIOLOGICAL).
Who is sponsoring clinical trial NCT01509404?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01509404's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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