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

Locations

5 United States sites

4 Egypt sites

2 United Kingdom sites

1 Canada site

1 Saudi Arabia site

Age

> 3 Years

Phase

Phase 4

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

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.

participation requirements

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.

participation restrictions

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

Locations

  • Oakland, California, United States, UCSF Benioff Children's Hospital Oakland, 94609
  • Ann Arbor, Michigan, United States, University of Michigan Comprehensive Cancer Center, 48109
  • Detroit, Michigan, United States, Children's Hospital of Michigan, 48201
  • Philadelphia, Pennsylvania, United States, The Children's Hospital of Philadephia, 19104-4399
  • Charleston, South Carolina, United States, Medical University of South Carolina, 29425
  • Toronto, Ontario, Canada, Hospital for Sick Kids
  • Alexandria, Egypt, Zagazig University
  • Cairo, Egypt, Ain Shams University
  • Cairo, Egypt, Cairo University
  • Cairo, Egypt, Pediatric Hospital of Cairo University
  • Abha, Saudi Arabia, Asser Central Hospital
  • London, United Kingdom, Barts and The London
  • London, United Kingdom, Evelina Children's Hospital