Protocol No.: HIE-RLS-0071

A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS0071 in Newborns with Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia with Long-Term Follow-Up (STAR)
Principal Investigator
Polak, Mark
Phase
II
Age Group
Children
Applicable Disease Site
Pediatrics
Participating Institutions
Health Sciences Center
West Virginia University
Contacts
Michelle Shaffer
Clinical Research Assoc
Phone: +1 304-293-2081
Robin Hoffer
Phone: +1 724-972-9170