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NCT05564598 · ClinicalTrials.gov registry record · Phase 2
CMV CTLs in Neonates With CMV Infection
A Phase 2 study of Congenital Cytomegaloviral (CMV) Disease, sponsored by New York Medical College.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
- 4
- Study locations
NCT05564598 is a Phase 2 study of Congenital Cytomegaloviral (CMV) Disease that is actively recruiting participants, run by New York Medical College. The registered enrollment target is 23 participants. The trial reports 4 study locations across 4 states.
The verdict
NCT05564598, a Phase 2 study of Congenital Cytomegaloviral (CMV) Disease, is actively recruiting participants, sponsored by New York Medical College.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
- 4
- Study locations
Study Summary
Patients with moderate or severe CMV disease less than 21 days old who have a maternal donor who has a CMV response to the peptivators will be screened. All patients will receive treatment with valganciclovir or ganciclovir. There is a safety run in with treatment with CMV CTLs in cohort 1 and if found to be safe, will proceed to cohort 2 for randomization to receive antiviral therapy with or without CMV CTLs. Funding source: FDA OOPD
Conditions Studied
Interventions
- BIOLOGICAL CMV Cytotoxic T-Lymphocytes
- DRUG Anti-viral Therapy
Study Locations (4)
California
- Children's Hospital Los Angeles - Los Angeles
Missouri
- Washington University - St Louis
New York
- New York Medical College - Vallhala
Ohio
- Nationwide Children's Hosptial - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2028-10-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05564598
The ClinicalTrials.gov registry entry for NCT05564598 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York Medical College, which has 47 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Congenital Cytomegaloviral (CMV) Disease appearing as the primary indexed condition, and to 2 interventions - of which CMV Cytotoxic T-Lymphocytes is the first listed.
NCT05564598 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT05564598 about?
NCT05564598 is a clinical study titled "CMV CTLs in Neonates With CMV Infection". Patients with moderate or severe CMV disease less than 21 days old who have a maternal donor who has a CMV response to the peptivators will be screened. All patients will receive treatment with valganciclovir or ganciclovir. There is a safety run in with treatment with CMV CTLs in cohort 1 and if f...
What is the current status of trial NCT05564598?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2023-07-01. Estimated completion is 2028-10-31.
What conditions does trial NCT05564598 study?
This clinical trial studies the following conditions: Congenital Cytomegaloviral (CMV) Disease.
What interventions are being tested in trial NCT05564598?
The interventions under investigation include: CMV Cytotoxic T-Lymphocytes (BIOLOGICAL), Anti-viral Therapy (DRUG).
Who is sponsoring clinical trial NCT05564598?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05564598 being conducted?
This trial has 4 study locations across California, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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