Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01362595 · ClinicalTrials.gov registry record · Phase 1
Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia
A Phase 1 study, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01362595 is a Phase 1 study that has completed, run by Northwell Health. The registered enrollment target is 55 participants.
The verdict
NCT01362595, a Phase 1 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This study will determine the safety and possibility of giving the amino acid, leucine, in patients with Diamond Blackfan anemia(DBA)who are on dependent on red blood cell transfusions. The leucine is expected to produce a response in patients with DBA to the point where red blood cell production is increased. Red cell transfusions can then be less frequent or possibly discontinued. The investigators will study the side effects, if any, of giving leucine to DBA patients. Leucine levels of leucine will be obtained at baseline and during the study. The drug leucine will be provided in capsule form and taken 3 times a day for a total of 9 months.
Interventions
- DRUG leucine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2013-06 |
| Est. Completion | 2020-11-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01362595
The ClinicalTrials.gov registry entry for NCT01362595 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which leucine is the first listed.
NCT01362595 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01362595 about?
NCT01362595 is a clinical study titled "Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia". This study will determine the safety and possibility of giving the amino acid, leucine, in patients with Diamond Blackfan anemia(DBA)who are on dependent on red blood cell transfusions. The leucine is expected to produce a response in patients with DBA to the point where red blood cell production i...
What is the current status of trial NCT01362595?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2013-06. Estimated completion is 2020-11-30.
What interventions are being tested in trial NCT01362595?
The interventions under investigation include: leucine (DRUG).
Who is sponsoring clinical trial NCT01362595?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.