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Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy

RecruitingPhase 2Ages any - anyAllPharmazz, Inc.
NCT05514340 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Either sex with ≥ 36 weeks of gestational age 2. Receiving supportive management for perinatal asphyxia 3. Perinatal depression, based on at least one of the following: * Apgar score of \<5 at 10 minutes * Need for resuscitation (chest compressions or mechanical ventilation) at birth * pH \<7.00 or base deficit ≥ 16 mmol/liter in the cord or arterial blood within 60 minutes of birth * Moderate/severe encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth. 4. Informed consent by one of the parents or a legal representative Exclusion Criteria: 1. Gestational age \<36 weeks 2. Admitted to hospital 12-hours after birth 3. A genetic or congenital condition that affects neuronal development 4. TORCH infection 5. Neonatal sepsis 6. Complex congenital heart disease 7. Severe dysmorphic feature 8. Microcephaly (head circumference \< 2 Standard Deviations below mean for gestational age)
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What it tests

  • Normal Saline along with standard treatment
  • Sovateltide along with standard treatment
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Where

4 sites
Father Muller Medical College Hospital
Mangalore, India
Christian Medical College and Hospital
Ludhiana, India
Niloufer Hospital
Hyderabad, India
GSVM Medical College
Kanpur, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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