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NCT02811263 · ClinicalTrials.gov registry record · Phase 3
High-dose Erythropoietin for Asphyxia and Encephalopathy
A Phase 3 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
NCT02811263: Completed Phase 3 study, sponsored by University of California, San Francisco.
NCT02811263 is a Phase 3 study that has completed, run by University of California, San Francisco. The registered enrollment target is 500 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02811263, a Phase 3 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
Study Summary
Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen to the brain near the time of birth. This results in death or neurologic disabilities including cerebral palsy and cognitive impairment in up to half of affected infants. This clinical trial will determine if the drug erythropoietin (Epo) added to hypothermia (usual therapy) will improve outcomes for infants suffering from HIE.
Primary Outcome
Neurodevelopmental impairment defined as any of the following: a) Gross Motor Function Scale (GMFCS) level ≥ 1, or b) GMFCS = 0 or 0.5 and cerebral palsy (CP) (any type), or c) Bayley III Cognitive Score \< 90
Interventions
- DRUG Normal saline placebo
- DRUG Erythropoietin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2017-01 |
| Est. Completion | 2022-04 |
| Phase | Phase 3 |
What the finished NCT02811263 record still lists
NCT02811263 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal saline placebo is the first listed.
NCT02811263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02811263 about?
NCT02811263 is a clinical study titled "High-dose Erythropoietin for Asphyxia and Encephalopathy". Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen to the brain near the time of birth. This results in death or neurologic disabilities including cerebral palsy and cognitive impairment in up to half of affected infants. This clinical trial will determine if...
What is the current status of trial NCT02811263?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2017-01. Estimated completion is 2022-04.
What interventions are being tested in trial NCT02811263?
The interventions under investigation include: Normal saline placebo (DRUG), Erythropoietin (DRUG).
Who is sponsoring clinical trial NCT02811263?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02811263's enrollment target sits among peer trials
500 744th of 2000 higher than 1,226 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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