Actively Recruiting
Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
Led by Pharmazz, Inc. · Updated on 2025-12-31
40
Participants Needed
4
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Baby born at or after 36 weeks of gestational age
- Receiving supportive management for perinatal asphyxia
- Perinatal depression indicated by at least one of:
- Apgar score below 5 at 10 minutes
- Need for resuscitation at birth (chest compressions or mechanical ventilation)
- pH below 7.00 or base deficit 16 mmol/liter or higher in cord or arterial blood within 60 minutes of birth
- Moderate or severe encephalopathy shown by at least 3 of 6 modified Sarnat criteria between 1 to 6 hours after birth
- Informed consent provided by a parent or legal representative
You will not qualify if you...
- Baby born before 36 weeks of gestation
- Hospital admission more than 12 hours after birth
- Presence of genetic or congenital conditions affecting neuronal development
- Diagnosis of TORCH infection
- Diagnosis of neonatal sepsis
- Complex congenital heart disease
- Severe abnormal body features (dysmorphic features)
- Microcephaly with head circumference more than 2 standard deviations below the mean for gestational age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Father Muller Medical College Hospital
Mangalore, Karnataka, India, 575002
Actively Recruiting
2
Christian Medical College and Hospital
Ludhiana, Punjab, India, 141008
Actively Recruiting
3
Niloufer Hospital
Hyderabad, Telangana, India, 500 004
Not Yet Recruiting
4
GSVM Medical College
Kanpur, Uttar Pradesh, India, 208002
Not Yet Recruiting
Research Team
M
Manish S Lavhale
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here