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NCT02075970 · ClinicalTrials.gov registry record · Phase 2
Optimized Erythropoietin (EPO) Treatment
A Phase 2 study, sponsored by John A Widness.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT02075970: Completed Phase 2 study, sponsored by John A Widness.
NCT02075970 is a Phase 2 study that has completed, run by John A Widness. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02075970, a Phase 2 study, has completed, sponsored by John A Widness.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study Summary
Neonatal anemia is the most commonly encountered hematologic problem among all neonates cared for in the neonatal intensive care unit (NICU). This project seeks to better understand the pathophysiology and treatment of this challenging and important condition, especially as it affects premature, critically ill very low birth weight (VLBW) infants who require intensive laboratory blood monitoring leading to the need for multiple red blood cell (RBC) transfusions (RBCTX). In the research strategy proposed in Study 1, Aims 1, 2 and 3, recombinant human erythropoietin (Epoetin Alpha, PROCRIT, provided by Janssen Scientific Affairs) will first be administered to 1.0 to 1.5 kg VLBW infants; then comprehensive pharmacokinetics (PK) and pharmacodynamics (PD) data will be systematically gathered and analyzed to identify clinical and laboratory covariate parameters differentiating the infants based on their level of Epoetin Alpha responsiveness. Finally the Epoetin Alpha responsiveness predictors thus determined will be applied prospectively in the Aim 4 Study, a 2 x 2 design in which VLBW infants will be identified as good or poor Epoetin Alpha responders, based on the predictors, and then randomly assigned to receive Epoetin Alpha treatment or no treatment. This will test the central hypothesis: RBCTX can be eliminated in the majority of good Epoetin Alpha responders by optimal administration of Epoetin Alpha, but only marginal reductions in RBCTx will occur in the poor Epoetin Alpha responders. This project challenges the prevailing thinking that the efficacy of Epoetin Alpha dosing in stimulating erythropoiesis is insufficient to eliminate the need for RBC transfusions in VLBW infants. Based on extensive preclinical and clinical PK/PD studies by our PPG team, we contend that previous Erythropoietin treatment studies in VLBW infants were not able to realize the full potential of Erythropoietin to eliminate RBCTX (in contrast to the very successful use of Erythropoietin in
Primary Outcome
The count of the number of packed red blood cell transfusions an infant receives during the entire course of their initial hospital stay.
Interventions
- DRUG Epoetin Alpha
- DRUG Biotinylated Red Blood Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2014-06 |
| Est. Completion | 2019-12 |
| Phase | Phase 2 |
What the finished NCT02075970 record still lists
NCT02075970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Epoetin Alpha is the first listed.
NCT02075970 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02075970 about?
NCT02075970 is a clinical study titled "Optimized Erythropoietin (EPO) Treatment". Neonatal anemia is the most commonly encountered hematologic problem among all neonates cared for in the neonatal intensive care unit (NICU). This project seeks to better understand the pathophysiology and treatment of this challenging and important condition, especially as it affects premature, cri...
What is the current status of trial NCT02075970?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2014-06. Estimated completion is 2019-12.
What interventions are being tested in trial NCT02075970?
The interventions under investigation include: Epoetin Alpha (DRUG), Biotinylated Red Blood Cells (DRUG).
Who is sponsoring clinical trial NCT02075970?
This trial is sponsored by John A Widness, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02075970's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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