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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00529152
Other study ID # LA30-0307
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2007
Last updated August 25, 2009
Start date August 2007
Est. completion date July 2008

Study information

Verified date August 2009
Source ApoPharma
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Health and Population
Study type Interventional

Clinical Trial Summary

- The primary objective is to assess the safety of Ferriprox oral solution for the treatment of iron overload in pediatric patients with transfusion-dependent anemia.

- The secondary objective is to assess the efficacy of Ferriprox oral solution in reducing iron overload in pediatric patients with transfusion-dependent anemia.


Description:

This will be a multi-centre, open label, single treatment, uncontrolled study. A total of 100 iron-overloaded pediatric patients with transfusion-dependent anemia will be enrolled in the study.Eligible patients will receive Ferriprox (deferiprone) oral solution, 100 mg/mL, at a total daily dose of 75 mg/kg body weight or 100 mg/kg body weight, divided in three (3) doses, for 24 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group N/A to 10 Years
Eligibility Inclusion Criteria:

- Patients who are = 10 years of age.

- Patients who have a confirmed diagnosis of transfusion-dependent anemia, other than Blackfan-Diamond anemia, and have chronic iron overload requiring chelation therapy.

- Patients who are in a chronic transfusion program, and who have received at least eight (8) red blood cell transfusions per year for a minimum of one year.

- Patients who are iron overloaded as assessed by serum ferritin concentration greater than 1000 µg/L.

Exclusion Criteria:

- Patients who have a diagnosis of Blackfan-Diamond anemia.

- Patients who have experienced neutropenia/agranulocytosis (absolute neutrophil count (ANC) < 1.5 x 109/L) or thrombocytopenia (platelet count < 50.0 x 109/L).

- Patients who have had previous treatment with Ferriprox and presented serious adverse reaction or intolerance requiring withdrawal of Ferriprox.

- Patients with evidence of abnormal liver function (ALT level > 3 times the upper limit of normal; entry may be delayed until values return to normal).

- Patients with evidence of renal failure, characterized by serum creatinine level > 2 times the upper limit of normal; entry may be delayed until values return to normal.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Deferiprone
Ferriprox (deferiprone) oral solution will be given orally at a total daily dose of 75 mg/kg body weight or 100 mg/kg body weight, divided into 3 doses, for 24 weeks.

Locations

Country Name City State
Egypt Abo El Reish Hospital, Cairo University Cairo
Egypt Children Hospital, Ain Shams University Cairo
Indonesia Cipto Mangunkusumo National Hospital Jakarta
Malaysia University of Malaya Medical Center Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
ApoPharma

Countries where clinical trial is conducted

Egypt,  Indonesia,  Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of Adverse Events 24 Weeks Yes
Secondary Change in Serum Ferritin Concentration From Baseline. Baseline and 24 weeks No
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