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Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload

NCT03802916 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-07-16

Study results available
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Summary

Safety, tolerability, and acceptability of twice-daily dosing with deferiprone delayed-release (DR) tablets in patients with systemic iron overload.

Conditions

  • Iron Overload Due to Repeated Red Blood Cell Transfusions

Interventions

DRUG

Deferiprone DR tablets 1000 mg (Low dosage)

Deferiprone DR tablets 1000 mg

DRUG

Deferiprone DR tablets 1000 mg (High dosage)

Deferiprone DR tablets 1000 mg

Sponsors & Collaborators

  • ApoPharma

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-06
Primary Completion
2019-12-04
Completion
2019-12-19
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Greece
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03802916 on ClinicalTrials.gov