RECRUITING

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

Conditions

Hypoxic-Ischemic Encephalopathy Birth Asphyxia Anoxic brain injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE. RLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.

Official Title

A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose 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 With Long-Term Follow-Up

Quick Facts

Study Start:2023-07-27

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05778188

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 10 Hours

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. ≥ 36 weeks gestation. 2. Sentinel event prior to delivery such as abruption, tight nuchal cord, uterine rupture, profound bradycardia, shoulder dystocia, or cord prolapse or other acute event likely attributable for newborn depression at delivery or an acute change in the fetal status with a clinical presentation consistent with an acute sentinel event with no clearly defined etiology. 3. Moderate or severe encephalopathy based on at least one risk of encephalopathy criterion (a) and one clinical signs of encephalopathy criterion (b): 1. Risk of encephalopathy (either): * Blood gas drawn within 1 hour of birth, either arterial blood gas (ABG) (cord or infant) or venous blood gas (VBG) (infant) with pH ≤ 7.0 OR base deficit ≥ 16 mmol/L. * Blood gas drawn within 1 hour of birth, either ABG (cord or infant) or VBG (infant) with pH 7.01 to 7.15, a base deficit between 10 and 15.9 mmol/L, or a blood gas was not available, additional criteria are required: * Infant born after an acute perinatal event (eg, late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage or cardiorespiratory arrest) and the APGAR score ≤ 5 at 10 minutes OR * The infant required assisted ventilation ≥ 10 minutes after birth (ie, endotracheal or mask ventilation). 2. Clinical signs of encephalopathy (either/both): * Moderate/Severe encephalopathy on National Institute of Child Health and Human Development assessment. * Evidence of seizures (clinical and/or electroencephalogram). 4. Be eligible to receive therapeutic hypothermia. 5. Active whole-body cooling to be started prior to 6 hours of age (passive cooling is permitted prior to active whole body cooling). 6. Product of a singleton pregnancy. 7. Written informed consent obtained from parent or legal guardian.	1. Inability to enroll in the study and initiate the first dose of RLS-0071 within 10 hours of life. 2. Known major congenital and/or chromosomal abnormality(ies). 3. Severe growth restriction (birth weight ≤ 1800 g). 4. Prenatal diagnosis of brain abnormality or hydrocephalus. 5. Patient's head circumference is \< 30 cm. 6. 10-minute appearance, pulse, grimace, activity, and respiration (APGAR) score \< 2 7. Infants suspected of overwhelming sepsis or congenital infection based on the Investigator's clinical consideration at the time of enrollment. 8. Persistent severe hypotension unresponsive to inotropic support (requiring \>2 inotropes, not inclusive of hydrocortisone). 9. Persistent severe hypoxia in the setting of 100% fraction of inspired oxygen (FiO₂) and unresponsive to nitric oxide or requiring extracorporeal membrane oxygenation (ECMO). 10. Severe disseminated intravascular coagulation with clinical bleeding. 11. Neonatal encephalopathy believed to be due to a cause other than perinatal hypoxia (ie, other than HIE). 12. Moribund infants for whom withdrawal of care being considered. 13. Suspected or confirmed fetal alcohol syndrome or suspected substance withdraw seizures. 14. Any other condition that the investigator may consider would make the patient ineligible for the study or place the patient at an unacceptable risk (Note: this criterion would include a clinically significant \[eg, Grade 3 or 4\] intracranial hemorrhage).

Inclusion Criteria

Exclusion Criteria

1. ≥ 36 weeks gestation.
2. Sentinel event prior to delivery such as abruption, tight nuchal cord, uterine rupture, profound bradycardia, shoulder dystocia, or cord prolapse or other acute event likely attributable for newborn depression at delivery or an acute change in the fetal status with a clinical presentation consistent with an acute sentinel event with no clearly defined etiology.
3. Moderate or severe encephalopathy based on at least one risk of encephalopathy criterion (a) and one clinical signs of encephalopathy criterion (b):
1. Risk of encephalopathy (either):
* Blood gas drawn within 1 hour of birth, either arterial blood gas (ABG) (cord or infant) or venous blood gas (VBG) (infant) with pH ≤ 7.0 OR base deficit ≥ 16 mmol/L.
* Blood gas drawn within 1 hour of birth, either ABG (cord or infant) or VBG (infant) with pH 7.01 to 7.15, a base deficit between 10 and 15.9 mmol/L, or a blood gas was not available, additional criteria are required:
* Infant born after an acute perinatal event (eg, late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage or cardiorespiratory arrest) and the APGAR score ≤ 5 at 10 minutes OR
* The infant required assisted ventilation ≥ 10 minutes after birth (ie, endotracheal or mask ventilation).
2. Clinical signs of encephalopathy (either/both):
* Moderate/Severe encephalopathy on National Institute of Child Health and Human Development assessment.
* Evidence of seizures (clinical and/or electroencephalogram).
4. Be eligible to receive therapeutic hypothermia.
5. Active whole-body cooling to be started prior to 6 hours of age (passive cooling is permitted prior to active whole body cooling).
6. Product of a singleton pregnancy.
7. Written informed consent obtained from parent or legal guardian.

1. Inability to enroll in the study and initiate the first dose of RLS-0071 within 10 hours of life.
2. Known major congenital and/or chromosomal abnormality(ies).
3. Severe growth restriction (birth weight ≤ 1800 g).
4. Prenatal diagnosis of brain abnormality or hydrocephalus.
5. Patient's head circumference is \< 30 cm.
6. 10-minute appearance, pulse, grimace, activity, and respiration (APGAR) score \< 2
7. Infants suspected of overwhelming sepsis or congenital infection based on the Investigator's clinical consideration at the time of enrollment.
8. Persistent severe hypotension unresponsive to inotropic support (requiring \>2 inotropes, not inclusive of hydrocortisone).
9. Persistent severe hypoxia in the setting of 100% fraction of inspired oxygen (FiO₂) and unresponsive to nitric oxide or requiring extracorporeal membrane oxygenation (ECMO).
10. Severe disseminated intravascular coagulation with clinical bleeding.
11. Neonatal encephalopathy believed to be due to a cause other than perinatal hypoxia (ie, other than HIE).
12. Moribund infants for whom withdrawal of care being considered.
13. Suspected or confirmed fetal alcohol syndrome or suspected substance withdraw seizures.
14. Any other condition that the investigator may consider would make the patient ineligible for the study or place the patient at an unacceptable risk (Note: this criterion would include a clinically significant \[eg, Grade 3 or 4\] intracranial hemorrhage).

Contacts and Locations

Study Contact

Lori Upham

CONTACT

757-901-0331

lupham@realtals.com

Study Locations (Sites)

Study Site 016

Little Rock, Arkansas, 72202

United States

Study Site 013

Orange, California, 92868

United States

Study Site 020

San Diego, California, 92037

United States

Study Site 019

San Diego, California, 92123

United States

Study Site 001

Gainesville, Florida, 32608

United States

Study Site 018

Miami, Florida, 33143

United States

Study Site 010

Orlando, Florida, 32803

United States

Study Site 014

Indianapolis, Indiana, 46202

United States

Study Site 012

Lexington, Kentucky, 40536

United States

Study Site 002

Boston, Massachusetts, 02115

United States

Study Site 006

Saint Louis, Missouri, 63110

United States

Study Site 003

Durham, North Carolina, 27710

United States

Study Site 005

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: ReAlta Life Sciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-27

Study Completion Date2026-04

Study Record Updates

Study Start Date2023-07-27

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

Birth Asphyxia
Anoxic brain injury

Additional Relevant MeSH Terms

Hypoxic-Ischemic Encephalopathy