NCT00069862

Brief Summary

A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 2, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

First QC Date

October 2, 2003

Last Update Submit

March 4, 2015

Conditions

Beta-Thalassemia

Keywords

Beta Thalassemia

Outcome Measures

Primary Outcomes (3)

  • safety and tolerability

  • iron excretion in urine and stool

  • pharmacokinetic measurements

Interventions

Deferitrin (GT56-252)DRUG
desferoxamine (DFO)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Beta-thalassemia patients, 18 years of age or older, currently undergoing chronic blood transfusion therapy and iron chelation therapy who weigh more than 40 kg.
  • No clinically significant findings on physical exam, medical history, or screening laboratories.
  • Serum ferritin greater than 500 ng/mL, serum creatine creatinine within the normal range and platelet count greater than 100,000/mm3.
  • Willing and able to discontinue DFO or L1 for the period of study.
  • Woman of child-bearing potential must have a negative serum pregnancy test at screening and use a medically acceptable form of birth control during the study and for 1 month afterward. Male patients must also use barrier contraceptives during the study and for 1 month afterward.
  • Have a level of understanding and willingness to cooperate with the confinement and all procedures. Able to provide voluntary signed/dated written informed consent.

You may not qualify if:

  • Serious medical condition unrelated to Beta-Thalassemia.
  • Participation in a previous investigational drug study within 30 days preceding screening.
  • Patients with a known allergy to DFO that prevents chronic administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New York Presbyterian Hospital-Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

beta-Thalassemia

Interventions

4'-hydroxydesazadesferrithiocin

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 2, 2003

First Posted

October 3, 2003

Study Start

September 1, 2003

Study Completion

November 1, 2005

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

US(1)