RLS-0071 for Newborns with Hypoxic-Ischemic Encephalopathy
This study is testing a new drug called RLS-0071 for newborns with moderate or severe hypoxic-ischemic encephalopathy (HIE), a condition where the brain doesn't get enough oxygen or blood flow. HIE can lead to serious problems, and there are currently no specific drug treatments that improve outcomes. This study aims to see if RLS-0071 is safe and well-tolerated, and to get an early look at how well it might work. Some newborns will receive RLS-0071, while others will receive a placebo (an inactive substance like saline). We are looking for about 70 participants. The study is currently recruiting.
- Study design
- This is a Phase 2, randomized, double-blind, placebo-controlled study involving multiple sites and ascending doses. Approximately 70 newborns will participate.
- What's involved
- Participants will receive RLS-0071 or placebo by infusion for 72 hours, in addition to standard care. They will be monitored for safety through Day 14.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be observed for long-term safety until they reach 24 months of age.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
At a glance
Conditions
Where it's being run
15 sites across 11 statesWho to contact
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Inclusion
What this trial measures
- Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment group at Day 14Day 1 to Day 14
Number of participants with AEs and SAEs graded between Grade 1 (mild in severity) and Grade 5 (death related to AE).
- Frequency and severity of events of special interest and SAEs by treatment group at 24 monthsDay 1 to 24 months
Number of participants with events of special interest and SAEs graded between Grade 1 (mild in severity) and Grade 5 (death related to AE). Events of special interest are: autoimmune disorder, persistent hypotension, persistent pulmonary hypertension, acute kidney injury, major venous thrombosis, severe intracranial hemorrhage, pulmonary hemorrhage, culture proven sepsis, necrotizing enterocolitis, severe thrombocytopenia, hepatic dysfunction, hyperbilirubinemia, coagulopathy, hypocalcemia, cerebral palsy, developmental or speech delay, learning disability, and visual or hearing impairment.
- Frequency of premature discontinuation by treatment group due to AEs at Day 14Day 1 to Day 14
Number of participants who prematurely discontinue from the study due to AEs
- Acute brain injury at Day 4, assessed through magnetic resonance imaging (MRI), using a standardized scoring systemDay 4
Brain injury MRI score includes scoring extent of injury across 4 domains (Grey matter, White matter/cortex, Cerebellum, and Additional). A score of 0 indicates a normal brain MRI, whereas the maximum score of 57 indicates extensive bilateral injury.
- Acute brain injury at Day 12, assessed through magnetic resonance imaging (MRI), using a standardized scoring systemDay 12
Brain injury MRI score includes scoring extent of injury across 4 domains (Grey matter, White matter/cortex, Cerebellum, and Additional). A score of 0 indicates a normal brain MRI, whereas the maximum score of 57 indicates extensive bilateral injury.