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

Stopped early · Phase 4

Conditions studied: Iron Overload, Sickle Cell Disease, Other Anemias

In brief

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.

Key facts

Study ID

NCT02443545

Run by

ApoPharma

People needed

134

Starts

2015-05-21

Expected to finish

2019-08-21

Last updated by the study team

2024-01-10

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed study LA38-0411
• 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)
• 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
• 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.

You may not qualify if…

• Plan to participate in another clinical trial at any time from the day of enrollment until 30 days post-treatment in the current study
• 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 (alanine aminotransferase) ≥ 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.
• Pregnant, breastfeeding, or planning to become pregnant during the study period.
• 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

Where it is running

• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• The Children's Hospital of Philadephia — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Hospital for Sick Kids — Toronto, Ontario, Canada
• Zagazig University — Alexandria, Egypt
• Ain Shams University — Cairo, Egypt
• Cairo University — Cairo, Egypt
• Pediatric Hospital of Cairo University — Cairo, Egypt
• Asser Central Hospital — Abhā, Saudi Arabia
• Barts and The London — London, United Kingdom
• Evelina Children's Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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