Evaluating Sovateltide for treating brain injury in newborns
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase-II Trial to Assess Safety, and Efficacy of Sovateltide in the Treatment of Hypoxic-ischemic Encephalopathy in Neonates
PHASE2 · Pharmazz, Inc. · NCT05514340
This study is testing a new treatment called Sovateltide to see if it can help newborns with brain injuries caused by lack of oxygen during birth.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Pharmazz, Inc. (industry) |
| Locations | 4 sites (Mangalore, Karnataka and 3 other locations) |
| Trial ID | NCT05514340 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the safety and efficacy of Sovateltide, a novel treatment for hypoxic-ischemic encephalopathy (HIE) in neonates. HIE is a serious condition resulting from oxygen deprivation during birth, leading to significant neurological damage. The trial compares Sovateltide combined with standard supportive care against normal saline with standard care. The goal is to determine if Sovateltide can improve outcomes for infants suffering from this life-threatening condition, particularly since current treatments have limited success.
Who should consider this trial
Good fit: Ideal candidates are neonates with a gestational age of 36 weeks or more who are receiving supportive management for perinatal asphyxia.
Not a fit: Patients with gestational age less than 36 weeks or those with genetic conditions affecting neuronal development may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve neurological outcomes for infants affected by hypoxic-ischemic encephalopathy.
How similar studies have performed: While therapeutic hypothermia is the current standard of care, there are no pharmacotherapies proven effective for HIE, making this approach novel and potentially groundbreaking.
Eligibility criteria
Show full inclusion / exclusion 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 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)
Where this trial is running
Mangalore, Karnataka and 3 other locations
- Father Muller Medical College Hospital — Mangalore, Karnataka, India (RECRUITING)
- Christian Medical College and Hospital — Ludhiana, Punjab, India (RECRUITING)
- Niloufer Hospital — Hyderabad, Telangana, India (NOT_YET_RECRUITING)
- GSVM Medical College — Kanpur, Uttar Pradesh, India (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Manish S Lavhale
- Email: manish.lavhale@pharmazz.com
- Phone: +91 9873847397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia, Neonatal Encephalopathy, Cerebral Asphyxia