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Trial record 15 of 22 for:    "Hemosiderosis" | "Iron Chelating Agents"

Clinical Importance of Treating Iron Overload in Sickle Cell Disease

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: NCT00981370
Recruitment Status : Terminated (1 consented patient never started on study drug, lost to follow up)
First Posted : September 22, 2009
Results First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Thomas Coates, Children's Hospital Los Angeles

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Anemia, Sickle Cell
Transfusion Hemosiderosis
Intervention Drug: deferasirox
Enrollment 1
Recruitment Details Subjects recruited from local physicians and at CHLA.
Pre-assignment Details No groups for this study.
Arm/Group Title Group One
Hide Arm/Group Description No enrollment
Period Title: Overall Study
Started 0
Completed 0
Not Completed 0
Arm/Group Title Group 1
Hide Arm/Group Description First group of subjects to be enrolled.
Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Number Analyzed 0 participants
0
Gender  
Number Analyzed 0 participants
Female 0
Male 0
Liver Iron Concentration > 8mg/g dry weight  
Number Analyzed 0 participants
0
1.Primary Outcome
Title To Determine if Red Cell Survival as Assessed by Hemoglobin Level, Reticulocyte Count, Lactic Acid Dehydrogenase, and Plasma Hemoglobin in Sickle Cell Patients is Related to the Degree of Iron Overload
Hide Description [Not Specified]
Time Frame Baseline, 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1
Hide Arm/Group Description:
First group of subjects enrolled.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was not collected. Only 1 subject passed screening to be enrolled but was then lost to follow up and never started study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description No patients enrolled
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%)
Total   0/0 
1 consent patient, never treated, lost to follow up
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Coates, MD
Organization: Childrens Hospital Los Angeles
Phone: 323-361-2352
EMail: tcoates@chla.usc.edu
Publications:
Layout table for additonal information
Responsible Party: Thomas Coates, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT00981370     History of Changes
Other Study ID Numbers: CICL670AUS30T
First Submitted: September 21, 2009
First Posted: September 22, 2009
Results First Submitted: October 27, 2010
Results First Posted: February 8, 2017
Last Update Posted: February 8, 2017