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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 is a Phase 2 study that has completed, run by John A Widness. The registered enrollment target is 62 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02075970
The ClinicalTrials.gov registry entry for NCT02075970 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John A Widness, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Epoetin Alpha is the first listed.
NCT02075970 reports 0 study locations.
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.
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