Trial · NCT01825512

Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients

NCT01825512, Phase 3, Completed, Consorzio per Valutazioni Biologiche e Farmacologiche; results first posted 2021-04-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients. Trials, record NCT01825512. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01825512

On this page

Trial

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

Title: Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients
NCT number: NCT01825512
Status: Completed
Phases: Phase 3
Enrollment: 435 participants, actual
Lead sponsor: Consorzio per Valutazioni Biologiche e Farmacologiche
Conditions: Chronic Iron Overload
Interventions: Deferiprone, Deferasirox
First posted: 2013-04-05
Last updated: 2021-05-04
Results first posted: 2021-04-08

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Percentage of Successfully Chelated Patients	at baseline and after 12 months	Percentage of successfully chelated patients is assessed by serum ferritin levels (in all patients) and cardiac MRI T2\* (in patients above 10 years of age able to perform an MRI scan without sedation)
Secondary	Liver MRI	at baseline and after 12 months	Change in liver iron concentration (measured using liver MRI), assessed as difference between value at 12 months minus value at baseline.
Secondary	Cardiac MRI T2*	at baseline and after 12 months	Change in cardiac iron concentration (measured using cardiac MRI T2\), assessed as difference between value at 12 months minus value at baseline. MRI T2\ is a non-invasive method based on gradient echo (GRE) sequences, where T2\* represents the spin-spin relaxation times, measured in milliseconds. The faster the curve decreases (ie, the smaller T2\), the greater amount of iron is in the tissue. Treatment success was assessed as follows: if baseline cardiac T2\ was less than 20 ms, an increase of 10% or more after 1 year of treatment was defined as treatment success; if baseline cardiac T2\* was more than 20 ms, any increase or a decrease of less than 10% after 1 year of treatment was defined as treatment success.
Secondary	Ferritin Level	at baseline and after 12 months	Change in serum ferritin level, assessed as difference between value at 12 months minus value at baseline.

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	Percentage of Successfully Chelated Patients	at baseline and after 12 months	Per-protocol population 1 (PP1): number of patients for whom the primary composite efficacy endpoint data were available at baseline and after 1 year of treatment (271 subjects)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Liver MRI	at baseline and after 12 months	Per-protocol population 3 (PP3): number of patients for whom liver iron concentration were available at baseline and after 1 year of treatment (106 subjects)	mg/g	MEAN
SECONDARY	Cardiac MRI T2*	at baseline and after 12 months	Per-protocol population 3 (PP3): number of patients for whom cardiac T2\* concentration were available at baseline and after 1 year of treatment (108 subjects)	milliseconds (ms)	MEAN
SECONDARY	Ferritin Level	at baseline and after 12 months	Per-protocol population 2 (PP2): number of patients for whom the per-protocol centralised serum ferritin concentration data were available at baseline and after 1 year of treatment (303 subjects, this population was larger than PP1 because PP2 included patients who did not have cardiac T2\* data)	ng/mL	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Percentage of Successfully Chelated Patients	Deferiprone	69		Participants
Percentage of Successfully Chelated Patients	Deferasirox	80		Participants
Liver MRI	Deferiprone	-0.848	Standard Error 0.887	mg/g
Liver MRI	Deferasirox	-2.975	Standard Error 0.776	mg/g
Cardiac MRI T2*	Deferiprone	0.488	Standard Error 1.284	milliseconds (ms)
Cardiac MRI T2*	Deferasirox	1.121	Standard Error 1.169	milliseconds (ms)
Ferritin Level	Deferiprone	-397.583	Standard Error 121.794	ng/mL
Ferritin Level	Deferasirox	-398.184	Standard Error 110.619	ng/mL

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Baseline	STARTED	Deferiprone	194
Baseline	STARTED	Deferasirox	199
Baseline	COMPLETED	Deferiprone	193
Baseline	COMPLETED	Deferasirox	197
Baseline	NOT COMPLETED	Deferiprone	1
Baseline	NOT COMPLETED	Deferasirox	2
Treatment	STARTED	Deferiprone	193
Treatment	STARTED	Deferasirox	197
Treatment	COMPLETED	Deferiprone	140
Treatment	COMPLETED	Deferasirox	170

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events58

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	cough	Respiratory, thoracic and mediastinal disorders	Deferiprone	15	193	21
other	cough	Respiratory, thoracic and mediastinal disorders	Deferasirox	16	197	25
other	neutropenia	Blood and lymphatic system disorders	Deferiprone	18	193	26
other	neutropenia	Blood and lymphatic system disorders	Deferasirox	11	197	15
other	pyrexia	General disorders	Deferiprone	28	193	40
other	pyrexia	General disorders	Deferasirox	32	197	56
other	abdominal pain	General disorders	Deferiprone	20	193	24
other	abdominal pain	General disorders	Deferasirox	8	197	9
other	vomiting	General disorders	Deferiprone	33	193	42
other	vomiting	General disorders	Deferasirox	8	197	10

1 to 10 of 58Source ClinicalTrials.gov

See all 58 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Deferiprone	0	193
Total, all-cause mortality	Deferasirox	0	197
Total, other adverse events	Deferiprone	152	193
Total, other adverse events	Deferasirox	89	197
Total, serious adverse events	Deferiprone	13	193
Total, serious adverse events	Deferasirox	14	197

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32470438	DERIVED	PubMed
33926431	DERIVED	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 comparisons3

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

Comparison	Source
Deferiprone vs Deferasirox: Percentage of Successfully Chelated Patients	Trial comparisons
Deferiprone vs Deferasirox: deaths from any cause	Trial comparisons
Deferiprone vs Deferasirox: serious adverse events	Trial comparisons

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/NCT01825512

GET https://conductscience.org/api/trials/v1/NCT01825512/events?page=2

API reference For AI assistants