Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias



Status:Enrolling by invitation
Conditions:Anemia, Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:3 - Any
Updated:1/16/2019
Start Date:May 2015
End Date:April 2022

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Long-term Safety and Efficacy Study of Ferriprox® for the Treatment of Transfusional Iron Overload in Patients With Sickle Cell Disease or Other Anemias

This is a long-term follow-up to an earlier study, LA38-0411. Its purpose is to gather more
information about the safety and efficacy of deferiprone in patients with sickle cell disease
or other anemias who suffer from iron overload caused by regular blood transfusions.

Deferiprone (brand name Ferriprox®) is an iron chelator that is approved in the United States
and over 60 other countries for the treatment of iron overload in patients with thalassemia,
when other treatments are inadequate. This study has been designed to evaluate the long-term
efficacy, safety, and tolerability of deferiprone to treat iron overload in patients who have
sickle cell disease or other anemias.

Only patients who have completed an earlier study, LA38-0411, are eligible to enroll in this
one.

Inclusion Criteria:

1. Completed study LA38-0411

2. Females of childbearing potential must have a negative pregnancy test result at Visit
1. In addition, if applicable, they must:

- Use an effective method of contraception according to local requirements, during
the study and within 30 days following their last dose of study medication, OR

- Have had a tubal ligation (supporting evidence required), OR

- Have had a hysterectomy (supporting evidence required), OR

- Participate in a non-heterosexual lifestyle, OR

- Have a male sexual partner who has been sterilized (supporting evidence required)

3. Fertile heterosexual males and/or their partners must agree to use an effective method
of contraception during the study and for 30 days following the last dose of study
medication

4. All patients and/or their authorized legal representatives must provide signed and
dated written informed consent prior to the first study intervention, and assent will
be obtained from patients who are considered to be minors. Patients must be able to
adhere to study restrictions, appointments, and evaluation schedules.

Exclusion Criteria:

1. Plan to participate in another clinical trial at any time from the day of enrollment
until 30 days post-treatment in the current study

2. For only those patients who were treated with deferoxamine in study LA38-0411 (Group
2): Presence of any medical condition (including clinically significant laboratory
abnormalities, such as ALT ≥ 5 x ULN or creatinine ≥ 2 x ULN), psychological
condition, or psychiatric condition which in the opinion of the investigator would
cause participation in the study to be unwise.

3. Pregnant, breastfeeding, or planning to become pregnant during the study period.

4. Treatment failure after 1 year on deferiprone which in the investigator's judgment
indicates the need for the patient to be started on a different iron chelator
We found this trial at
6
sites
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Oakland, California 94609
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Philadelphia, Pennsylvania 19104
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555 University Avenue
Toronto, Ontario M5G 1X8
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Toronto,
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