Trial · NCT02443545

Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias

NCT02443545, Phase 4, Terminated, ApoPharma; results first posted 2024-01-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias. Trials, record NCT02443545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02443545

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias
NCT number: NCT02443545
Status: Terminated
Phases: Phase 4
Enrollment: 134 participants, actual
Lead sponsor: ApoPharma
Conditions: Iron Overload, Sickle Cell Disease, Other Anemias
Interventions: Deferiprone
First posted: 2015-05-14
Last updated: 2024-01-10
Results first posted: 2024-01-10
Limitations and caveats: The trial was terminated early upon recommendation of the Data and Safety Monitoring Board (DSMB), which felt that sufficient information had been obtained.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients With Adverse Events	From the first day of the study until the last study visit (Week 104 or early termination)	Number of patients with at least one adverse event (AE) of any type; number of patients with at least one serious adverse event, and number of patients who withdrew from the study due to an AE
Secondary	Change From Baseline in Liver Iron Concentration (LIC)	One year, two years, and three years after the start of deferiprone therapy	LIC was measured by MRI, in units of mg of iron per gram of liver (dry weight). The change from baseline in LIC was determined for three different periods of exposure to deferiprone: one year, two years, and three years.
Secondary	Change From Baseline in Cardiac MRI T2*	One year, two years, and three years after the start of deferiprone therapy	The change from baseline in cardiac MRI T2\* was determined for three different periods of exposure to deferiprone: one year, two years, and three years
Secondary	Change From Baseline in Serum Ferritin	One year, two years, and three years after the start of deferiprone therapy	The change from baseline in serum ferritin (SF) was determined for three different periods of exposure to deferiprone: one year, two years, and three years.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Patients With Adverse Events	From the first day of the study until the last study visit (Week 104 or early termination)	Safety population (all enrolled patients who took at least one dose of study drug)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Liver Iron Concentration (LIC)	One year, two years, and three years after the start of deferiprone therapy	Intent-to-Treat (ITT) population (patients who received at least one dose of study drug and had a baseline and at least one post-baseline efficacy assessment). LIC data for one year of exposure to deferiprone were obtained from 129 patients, data for two years from 112 patients, and data for three years from 59 patients.	mg of iron per gram of liver dry weight	MEAN
SECONDARY	Change From Baseline in Cardiac MRI T2*	One year, two years, and three years after the start of deferiprone therapy	ITT population. Cardiac MRI T2\* data for one year of exposure to deferiprone were obtained from 121 patients, data for two years from 110 patients, and data for three years from 58 patients.	milliseconds	MEAN
SECONDARY	Change From Baseline in Serum Ferritin	One year, two years, and three years after the start of deferiprone therapy	ITT population. Serum ferritin data for one year of exposure to deferiprone were obtained from 125 patients, data for two years from 96 patients, and data for three years from 55 patients.	micrograms per liter	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Patients With Adverse Events	Deferiprone	Number of patients with any type of adverse event	104		Participants
Number of Patients With Adverse Events	Deferiprone	Number of patients with a serious adverse event	35		Participants
Number of Patients With Adverse Events	Deferiprone	Number of patients who discontinued due to an AE	2		Participants
Change From Baseline in Liver Iron Concentration (LIC)	Deferiprone	Change from baseline in LIC after 1 year	-2.64	Standard Deviation 4.64	mg of iron per gram of liver dry weight
Change From Baseline in Liver Iron Concentration (LIC)	Deferiprone	Change from baseline in LIC after 2 years	-3.91	Standard Deviation 6.38	mg of iron per gram of liver dry weight
Change From Baseline in Liver Iron Concentration (LIC)	Deferiprone	Change from baseline in LIC after 3 years	-6.64	Standard Deviation 7.72	mg of iron per gram of liver dry weight
Change From Baseline in Cardiac MRI T2*	Deferiprone	Change from baseline in cardiac iron after 1 year	1.02	Standard Deviation 19.65	milliseconds
Change From Baseline in Cardiac MRI T2*	Deferiprone	Change from baseline in cardiac iron after 2 years	1.00	Standard Deviation 21.18	milliseconds
Change From Baseline in Cardiac MRI T2*	Deferiprone	Change from baseline in cardiac iron after 3 years	0.98	Standard Deviation 24.53	milliseconds
Change From Baseline in Serum Ferritin	Deferiprone	Change from baseline in SF after 1 year	-1	Standard Deviation 1986	micrograms per liter

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group 1: Deferiprone 3 Years	89
Overall Study	STARTED	Group 2: Deferiprone 2 Years	45
Overall Study	COMPLETED	Group 1: Deferiprone 3 Years	50
Overall Study	COMPLETED	Group 2: Deferiprone 2 Years	26
Overall Study	NOT COMPLETED	Group 1: Deferiprone 3 Years	39
Overall Study	NOT COMPLETED	Group 2: Deferiprone 2 Years	19

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Sickle cell anaemia with crisis	Blood and lymphatic system disorders	Deferiprone	17	134	39
other	Abdominal pain	Gastrointestinal disorders	Deferiprone	26	134	44
other	Vomiting	Gastrointestinal disorders	Deferiprone	9	134	12
other	Pyrexia	General disorders	Deferiprone	33	134	50
other	Nasopharyngitis	Infections and infestations	Deferiprone	17	134	28
other	Pharyngitis	Infections and infestations	Deferiprone	10	134	15
other	Upper respiratory tract infection	Infections and infestations	Deferiprone	9	134	12
other	Neutrophil count decreased	Investigations	Deferiprone	16	134	29
other	Arthralgia	Musculoskeletal and connective tissue disorders	Deferiprone	10	134	15
other	Back pain	Musculoskeletal and connective tissue disorders	Deferiprone	17	134	51

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Deferiprone	1	134
Total, other adverse events	Deferiprone	99	134
Total, serious adverse events	Deferiprone	35	134

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36018224	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02443545

GET https://conductscience.org/api/trials/v1/NCT02443545/events?page=2

API reference For AI assistants