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Peptide
RLS-0071 for Hypoxic-Ischemic Encephalopathy (STAR Trial)
Phase 2
Recruiting
Research Sponsored by ReAlta Life Sciences, Inc.
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 3, 12, and 24 months
Awards & highlights
Summary
This trial studies a new drug to treat hypoxic-ischemic encephalopathy, a condition that affects 4-12k US people each year, and has a high mortality rate. It will evaluate safety and tolerability in newborns with moderate-severe HIE.
Who is the study for?
This trial is for newborns with moderate or severe brain injury due to lack of oxygen (HIE) who are undergoing cooling therapy. They must be from a single birth, at least 36 weeks gestation, and have specific signs of encephalopathy before cooling starts. Babies with serious bleeding in the brain, suspected infections, extreme low blood pressure unresponsive to drugs, major congenital issues, or other non-HIE related brain injuries cannot participate.
What is being tested?
The study tests RLS-0071's safety and ability to tolerate it as a potential treatment for HIE in newborns compared to a placebo. Newborns will either receive RLS-0071 or an inactive substance while they undergo therapeutic hypothermia—a standard treatment where the baby's body temperature is lowered to help heal the brain.
What are the potential side effects?
As this is an early-stage trial evaluating safety and tolerability, specific side effects of RLS-0071 are not yet fully known but may include reactions at the injection site, changes in vital signs like heart rate or blood pressure, allergic reactions or no side effects at all.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 12, and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 12, and 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment group at Day 14
Frequency and severity of adverse events of special interest (AESIs) and SAEs by treatment group at 24 months
Frequency of premature discontinuation by treatment group due to AEs at Day 14
Secondary study objectives
Brain injury MRI score at Day 12 for the grey matter injury domain
Brain injury score at Day 12, as assessed through magnetic resonance imaging (MRI), using a standardized scoring system for the white matter injury domain
Early neonatal mortality at Day 14
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RLS-0071Experimental Treatment1 Intervention
Doses of RLS-0071 to be administered every 8 hours (q8h), for a total of 10 doses over 72 hours.
Group II: PlaceboPlacebo Group1 Intervention
Doses of sterile saline (sodium chloride, 0.9%) to be administered every 8 hours (q8h), for a total of 10 doses over 72 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RLS-0071
2021
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
ReAlta Life Sciences, Inc.Lead Sponsor
5 Previous Clinical Trials
176 Total Patients Enrolled
Premier Research Group plcIndustry Sponsor
62 Previous Clinical Trials
73,827 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My unborn baby has been diagnosed with a brain issue or hydrocephalus.I have a known major genetic or chromosomal abnormality.I cannot start the study drug within 10 hours of birth.I have severe blood clotting and bleeding issues.I have low blood pressure that doesn't improve with medication.I need advanced support to breathe despite receiving 100% oxygen.My head circumference is less than 30 cm.My infant might have a severe infection or was born with an infection.My newborn has brain dysfunction not caused by birth-related oxygen deprivation.I am eligible for cold temperature treatment.I have moderate or severe confusion due to liver problems.My baby started whole-body cooling before 6 hours old.My birth weight was 1800 g or less.
Research Study Groups:
This trial has the following groups:- Group 1: RLS-0071
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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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