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Antiviral
CMV-Specific Immunotherapy for Congenital Cytomegalovirus Disease
Phase 2
Recruiting
Led By Mitchell Cairo, MD
Research Sponsored by New York Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Summary
This trial is for a new treatment for CMV in newborns. It is a safety trial to see if the new treatment is safe and effective.
Who is the study for?
This trial is for newborns under 21 days old with moderate to severe CMV disease, weighing at least 2500 grams and born after at least 34 weeks of gestation. They must have a maternal donor with an immune response to CMV. Babies on high-dose steroids, in other CMV trials, or with certain medical conditions can't participate.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of adding CMV-specific T-cells (CMV CTLs) from the mother to standard antiviral therapy (valganciclovir or ganciclovir) in treating congenital CMV infection in neonates.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion of T-cells and those associated with antiviral medications such as valganciclovir or ganciclovir, which may affect blood counts and kidney function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine response rates to treatment with CMV CTLS and anti-viral medication
Cytomegalovirus Infections
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2 Antiviral medication + CMV CTLsExperimental Treatment2 Interventions
Patients will receive both anti-viral medication and CMV CTLs
Group II: Cohort 1 Safety Run-inExperimental Treatment2 Interventions
The first 3 patients enrolled will receive both anti-viral medication and CMV CTLs, and treatment will be staggered every 28 days from the last dose of CMV CTLs from the prior patient.
Group III: Cohort 2 Antiviral medication onlyActive Control1 Intervention
Patients will only receive anti-viral therapy
Find a Location
Who is running the clinical trial?
New York Medical CollegeLead Sponsor
70 Previous Clinical Trials
6,110 Total Patients Enrolled
Mitchell Cairo, MDPrincipal InvestigatorNew York Medical College
13 Previous Clinical Trials
313 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have inflammation in the back of my eye.My white blood cell count is high for my age in my central nervous system.My blood, kidney, and liver tests meet the required levels.I have moderate or severe CMV disease.I am taking steroids equivalent to more than 0.5 mg/kg of prednisone on the day of my treatment.I have severe hearing loss from birth.I am 21 days old or younger.My spleen is enlarged.My legal representative cannot follow the study rules or give consent for me.I have a brain malformation.I have multiple small red or purple spots on my skin.My mother has a history of HIV infection.I have a maternal donor with a suitable immune response for my treatment.I am at least 34 weeks pregnant.I have an enlarged liver.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 Safety Run-in
- Group 2: Cohort 2 Antiviral medication + CMV CTLs
- Group 3: Cohort 2 Antiviral medication only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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