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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 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 40 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01509404
The ClinicalTrials.gov registry entry for NCT01509404 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Valganciclovir is the first listed.
NCT01509404 reports 0 study locations.
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.
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