Phase
Condition
Red Blood Cell Disorders
Sickle Cell Disease
Anemia
Treatment
Deferiprone
Clinical Study ID
Ages > 3 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Completed study LA38-0411
- Females of childbearing potential must have a negative pregnancy test result at Visit
- In addition, if applicable, they must:
- Use an effective method of contraception according to local requirements, duringthe 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 methodof contraception during the study and for 30 days following the last dose of studymedication
- All patients and/or their authorized legal representatives must provide signed anddated written informed consent prior to the first study intervention, and assent willbe obtained from patients who are considered to be minors. Patients must be able toadhere to study restrictions, appointments, and evaluation schedules.
Exclusion
Exclusion Criteria:
- Plan to participate in another clinical trial at any time from the day of enrollmentuntil 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 laboratoryabnormalities, such as ALT (alanine aminotransferase) ≥ 5 x ULN or creatinine ≥ 2 xULN), psychological condition, or psychiatric condition which in the opinion of theinvestigator 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 judgmentindicates the need for the patient to be started on a different iron chelator
Study Design
Study Description
Connect with a study center
Centro Infantil Boldrini
Campinas,
BrazilSite Not Available
Hospital de Clínicas de Porto Alegre
Porto Alegre,
BrazilSite Not Available
Instituto Estadual de Hematologia
Rio de Janeiro,
BrazilSite Not Available
Casa de Saúde Santa Marcelina
São Paulo,
BrazilSite Not Available
Hospital for Sick Kids
Toronto, Ontario
CanadaSite Not Available
Zagazig University
Alexandria,
EgyptSite Not Available
Ain Shams University
Cairo,
EgyptSite Not Available
Cairo University
Cairo,
EgyptSite Not Available
Pediatric Hospital of Cairo University
Cairo,
EgyptSite Not Available
Mansoura University Children's Hospital
Mansoura,
EgyptSite Not Available
Asser Central Hospital
Abha,
Saudi ArabiaSite Not Available
King Abdulaziz University Hospital
Jeddah,
Saudi ArabiaSite Not Available
King Khalid University Hospital
Riyadh,
Saudi ArabiaSite Not Available
Barts and The London
London,
United KingdomSite Not Available
Evelina Children's Hospital
London,
United KingdomSite Not Available
UCSF Benioff Children's Hospital Oakland
Oakland, California 94609
United StatesSite Not Available
University of Illinois at Chicago
Chicago, Illinois 60612
United StatesSite Not Available
Children's Hospital
New Orleans, Louisiana 70118
United StatesSite Not Available
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
United StatesSite Not Available
Children's Hospital of Michigan
Detroit, Michigan 48201
United StatesSite Not Available
The Children's Hospital of Philadephia
Philadelphia, Pennsylvania 19104-4399
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
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