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Iron Chelator

Deferiprone for Iron Overload

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year, two years, and three years after the start of deferiprone therapy for reporting.

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 • NCT01770652

13%

Headache

100%

80%

60%

40%

20%

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

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