Trial · NCT05514340
Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
NCT05514340, Phase 2, Recruiting, Pharmazz, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy. Trials, record NCT05514340. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05514340
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
- NCT number
- NCT05514340
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Pharmazz, Inc.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia, Neonatal Encephalopathy
- Interventions
- Normal Saline along with standard treatment, Sovateltide along with standard treatment
- First posted
- 2022-08-24
- Last updated
- 2025-12-31
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of patients with death or disability (moderate/severe) | 24 months | Percentage of patients with death or disability (moderate/severe). Severe disability is defined as any of the following: a Bayley composite cognitive score \<70, a GMFCS grade of level 3 to 5, hearing impairment requiring hearing aids, or blindness (vision \<20/200). Moderate disability is defined as a composite cognitive score 70 - 84, in addition, one or more of the following: GMFCS grade of level 2, unilateral blindness (vision 20/200 in only one eye), or hearing impairment with no amplification/cochlear implant. |
| Secondary | Bayley Scales of Infant and Toddler Development Scores | 24 months | Changes in Bayley Scales of Infant and Toddler Development Scores. Cognitive, Language, Motor, Social-Emotional, and General Adaptive Scales Score as assessed by Bayley Scales of Infant and Toddler Development (BSID)TM measured at 6 months after initiation of treatment and then at every 6 months interval. |
| Secondary | Disabling cerebral palsy | 24 months | Change in the proportion of children with disabling cerebral palsy |
| Secondary | Seizures | 24 months | Change in the proportion of patients with seizures. Clinical or electrical seizures at birth, at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 7 days, 30 days, 6 months after initiation of treatment, and then at every 6 months interval. |
| Secondary | Brain injury | 14 days] | The number of patients with brain injury (MRI or EEG evidence of brain injury). Abnormal MRI findings based on NICHD neonatal network score within 1 to 2 weeks of initiation of treatment. |
| Secondary | Blindness or hearing impairment | 24 months | Change in the proportion of patients with blindness or hearing impairment |
| Secondary | Adverse events | 24 months | Incidence of sovateltide-related adverse events |
| Secondary | Tolerance | 7 days | The number of patients not receiving complete treatment due to intolerance to sovateltide. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05514340
GET https://conductscience.org/api/trials/v1/NCT05514340/registered