Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPharmazz, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Either sex with ≥ 36 weeks of gestational age
Receiving supportive management for perinatal asphyxia
Apgar score of <5 at 10 minutes
Need for resuscitation (chest compressions or mechanical ventilation) at birth
Disqualifiers
Gestational age <36 weeks
Admitted to hospital 12-hours after birth
A genetic or congenital condition that affects neuronal development
TORCH infection
Trial design
Treatments tested in this trial
- Normal Saline along with standard treatment
- Sovateltide along with standard treatment
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
4Father Muller Medical College Hospital575002, MangaloreKarnataka, India
Christian Medical College and Hospital141008, LudhianaPunjab, India
Niloufer Hospital500 004, HyderabadTelangana, India
GSVM Medical College208002, KanpurUttar Pradesh, India
Sponsors and collaborators
Pharmazz, Inc.
Lead sponsor
Source ClinicalTrials.gov