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Completed Phase 3 Interventional Accepts healthy volunteers Results available

A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)

NCT01376778
Conditions
Congenital Cytomegalovirus Infection, Maternal Cytomegalovirus Infection
Interventions
CMV hyperimmune globulin, Placebo
Drug · Other
Lead sponsor
The George Washington University Biostatistics Center
Other
Eligibility
Female only
Enrollment
399 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2021
U.S. locations
16
States / cities
Birmingham, Alabama • Stanford, California • Aurora, Colorado + 13 more
Conditions
Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy
Interventions
Intravenously administered pooled human immunoglobulin (IVIG)
Biological
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
16 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
5
States / cities
Birmingham, Alabama • Baltimore, Maryland • Pittsburgh, Pennsylvania + 2 more