Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
Recruiting
Phase 2
Interventional Study
Hypoxic-Ischemic Encephalopathy
Neonatal Asphyxia
Neonatal Encephalopathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 40 (estimated)
- Sponsor
- Pharmazz, Inc. · Industry
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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 …
Trial Locations
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Eligibility Criteria
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 ventil…
Contacts