Cohort 2 Antiviral medication + CMV CTLs for Congenital Cytomegalovirus (CMV) Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Congenital Cytomegalovirus (CMV) Disease+1 MoreAnti-viral Therapy - Drug
Eligibility
No minimum age - 21
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Congenital Cytomegalovirus (CMV) Disease
  • Neonatal CMV Disease

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 12 weeks

12 weeks
To determine response rates to treatment with CMV CTLS and anti-viral medication
Cytomegalovirus Infections

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Cohort 2 Antiviral medication only
1 of 3
Cohort 2 Antiviral medication + CMV CTLs
1 of 3
Cohort 1 Safety Run-in
1 of 3

Active Control

Experimental Treatment

23 Total Participants · 3 Treatment Groups

Primary Treatment: Cohort 2 Antiviral medication + CMV CTLs · No Placebo Group · Phase 2

Cohort 2 Antiviral medication + CMV CTLsExperimental Group · 2 Interventions: Anti-viral Therapy, CMV Cytotoxic T-Lymphocytes · Intervention Types: Drug, Biological
Cohort 1 Safety Run-inExperimental Group · 2 Interventions: Anti-viral Therapy, CMV Cytotoxic T-Lymphocytes · Intervention Types: Drug, Biological
Cohort 2 Antiviral medication only
Drug
ActiveComparator Group · 1 Intervention: Anti-viral Therapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Who is running the clinical trial?

New York Medical CollegeLead Sponsor
65 Previous Clinical Trials
5,661 Total Patients Enrolled
Mitchell Cairo, MDPrincipal InvestigatorNew York Medical College
12 Previous Clinical Trials
331 Total Patients Enrolled

Eligibility Criteria

Age No minimum age - 21 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a gestational age of ≤ 21 days of life.
Birth weight ≥ 2500 gms.
You have a moderate or severe CMV disease.
Thrombocytopenia (≤ 50,000 mm3) is present.
You have intrauterine growth retardation.