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Iron Chelator
Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias
Phase 4
Waitlist Available
Led By Janet Kwiatkowski, MD
Research Sponsored by ApoPharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year, two years, and three years after the start of deferiprone therapy
Awards & highlights
Drug Has Already Been Approved
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is studying the safety and effectiveness of deferiprone, a medication that removes excess iron, in patients with sickle cell disease or other anemias who have too much iron from frequent blood transfusions. Deferiprone is an oral treatment that has been used to manage iron overload in patients with thalassemia and has shown positive results in various studies.
Eligible Conditions
- Iron Overload
- Anemia
- Sickle Cell Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year, two years, and three years after the start of deferiprone therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year, two years, and three years after the start of deferiprone therapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients With Adverse Events
Secondary study objectives
Change From Baseline in Cardiac MRI T2*
Change From Baseline in Liver Iron Concentration (LIC)
Change From Baseline in Serum Ferritin
Side effects data
From 2013 Phase 4 trial • 32 Patients • NCT0177065213%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Severe Renal Impairment
Normal Hepatic Function (Healthy Volunteers)
Mild Renal Impairment
Moderate Renal Impairment
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group 2: Deferiprone 2 yearsExperimental Treatment1 Intervention
Patients in this group are those who were randomized to the deferoxamine arm in study LA38-0411, and hence will receive deferiprone for 2 years (both of them in the extension study).
Group II: Group 1: Deferiprone 3 yearsExperimental Treatment1 Intervention
Patients in this group are those who were randomized to the deferiprone arm in study LA38-0411, and hence will receive deferiprone for a total of 3 years (1 year in the initial study plus 2 years in the extension study).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deferiprone
FDA approved
Find a Location
Who is running the clinical trial?
ApoPharmaLead Sponsor
25 Previous Clinical Trials
2,152 Total Patients Enrolled
6 Trials studying Iron Overload
677 Patients Enrolled for Iron Overload
Janet Kwiatkowski, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
6 Previous Clinical Trials
969 Total Patients Enrolled
1 Trials studying Iron Overload
230 Patients Enrolled for Iron Overload