ClinicalTrials.gov

History of Changes for Study: NCT00901199
Combo Chelation Trial
Latest version (submitted July 20, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 12, 2009 None (earliest Version on record)
2 January 20, 2011 Study Status
3 May 7, 2012 Recruitment Status, Sponsor/Collaborators, Study Status and Contacts/Locations
4 August 5, 2013 Recruitment Status, Study Status, Study Design
Show
Results Submission Events
5 July 20, 2021 Arms and Interventions, Study Status, Outcome Measures, Study Design, Sponsor/Collaborators, Study Description, Results, References, Contacts/Locations and Study Identification
Comparison Format:

Scroll up to access the controls

Study NCT00901199
Submitted Date:  May 12, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: CICL670AUS24T
Brief Title: Combo Chelation Trial
Official Title: Safety of Deferasirox (ICL670) and Deferoxamine (Desferal or DFO) Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2009
Overall Status: Recruiting
Study Start: September 2007
Primary Completion: August 2010 [Anticipated]
Study Completion: August 2010 [Anticipated]
First Submitted: May 12, 2009
First Submitted that
Met QC Criteria:
May 12, 2009
First Posted: May 13, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 12, 2009
Last Update Posted: May 13, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: UCSF Benioff Children's Hospital Oakland
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is a small pilot study looking at the safety of giving combination chelation with Exjade and Desferal to 15 patients. The hypothesis is that combination chelation is safe in decreasing overall iron in patients with thalassemia.
Detailed Description:
Open or close this module Conditions
Conditions: Thalassemia
Iron Overload
Keywords: Thalassemia
Chelation
Iron Overload
Thalassemia patients with Iron overload
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 15 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Child Cohort
This is the cohort in the study for children ages 8-18 years old. All subjects in this arm must have Liver Iron by SQUID of between 5-15mg/g dry liver and have a documented endocrinopathy or cardiac finding (low T2* or decreased cardiac function). All subjects in this arm will receive 7 days per week of Exjade and 3-5 days per week of Desferal.
Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)
All subjects will be given Exjade 7 days per week 20-30mg/kg and Deferoxamine 3-7 days per week 50mg/kg. Days per week are dependent on how much iron overload subject has.
Other Names:
  • Exjade, ICL670 (deferisirox)
  • DFO, Desferal (deferoxamine)
Moderate Adult Cohort
Adults in this arm will have moderate iron overload,defined as SQUID of 5-15mg/g dry weight. They will also have to have a documented endocrinopathy or cardiac finding (low T2*). All subjects in this cohort will receive 7 days per week of Exjade (20-30mg/kg) and Desferal (50mg/kg)3-5 days per week.
Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)
All subjects will be given Exjade 7 days per week 20-30mg/kg and Deferoxamine 3-7 days per week 50mg/kg. Days per week are dependent on how much iron overload subject has.
Other Names:
  • Exjade, ICL670 (deferisirox)
  • DFO, Desferal (deferoxamine)
Adults cohort with high iron overload
Adults with high iron overload defined as over 15mg/g dry liver. No cardiac finding or endocrinopathy necessary. Subjects in this cohort will receive Exjade 20-30mg/kg 7 days per week and Desferal (50mg/kg)5-7 days per week.
Drug: Combo Chelation with Deferasirox (Exjade) and Desferal (DFO)
All subjects will be given Exjade 7 days per week 20-30mg/kg and Deferoxamine 3-7 days per week 50mg/kg. Days per week are dependent on how much iron overload subject has.
Other Names:
  • Exjade, ICL670 (deferisirox)
  • DFO, Desferal (deferoxamine)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Monitoring kidney function with urine protein/creatine levels
[ Time Frame: with transfusion ]

Open or close this module Eligibility
Minimum Age: 8 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Transfusion Dependent Thalassemia
  • If iron between 5-15 mg/g dry liver by SQUID, subject must have a documented endocrinopathy or cardiac finding
  • Older than 8 years

Exclusion Criteria:

  • Participating on another interventional clinical trial
Open or close this module Contacts/Locations
Central Contact Person: Nancy Sweeters, RN, PNP
Telephone: (510)428-3885 Ext. 4151
Email: nsweeters@mail.cho.org
Locations: United States, California
CHRCO
[Recruiting]
Oakland, California, United States, 94609
Contact:Contact: Nancy Sweeters, RN, PNP 510-428-3885 Ext. 4151 nsweeters@mail.cho.org
Contact:Principal Investigator: Elliott Vichinsky, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services