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Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia (LeucineDBA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01362595
Recruitment Status : Unknown
Verified February 2020 by Adrianna Vlachos, Northwell Health.
Recruitment status was:  Active, not recruiting
First Posted : May 30, 2011
Last Update Posted : February 18, 2020
Information provided by (Responsible Party):
Adrianna Vlachos, Northwell Health

Results Submitted - Not Posted on ClinicalTrials.gov
Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.
Recruitment Status : Unknown
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : April 30, 2020
Submission Cycle Results Submitted to ClinicalTrials.gov Results Returned after Quality Control Review
1 March 2, 2021
March 26, 2021
2 November 22, 2021
December 20, 2021
3 November 18, 2022
Lab Advisor(TM); Leucine Measurements in Micromedex (R) Healthcare Series. 2010Thomson Reuters
Jellin JM, Gregory P, Batz F. Pharmacist's letter/ Prescriber's Letter Natural Medicines Comprehensive Database, 3rd ed, Therapeutic Research Faculty, Stockton, CA, 2000.
Braverman ER. The Healing Nutrients Within. New Canaan, CT: Keats Publishing, Inc. 1997; 339
Gilman AG, Rall JW, Nies AD et al (eds): Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed. Pergamon Press, New York, NY, 1990.
AMA Department of Drugs; AMA Drug Evaluations, 6th ed. American Medical Association, Chicago, IL,1986.
Tietz NE (Ed); Clinical Guide to Laboratory Tests, 3rd ed W. B. Saunders, Philadelphia, PA, 1995.
Henry JB: Clinical Diagnosis and Management by Laboratory Methods, 20th ed. Saunders 2001.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):