Trial · NCT01090323

Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).

NCT01090323, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2011-01-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO). Trials, record NCT01090323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01090323

On this page

Trial

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

Title: Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).
NCT number: NCT01090323
Status: Completed
Phases: Phase 2
Enrollment: 185 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Sickle Cell Disease
Interventions: ICL670
First posted: 2010-03-19
Last updated: 2011-06-06
Other registries' IDs: eudract:2004-000597-31
Results first posted: 2011-01-20

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events After Start of ICL670	0 - 60 months	Safety as assessed by the number of participants with adverse event or death after the start of ICL670.
Secondary	Change in Serum Ferritin From Start of ICL670 to End of Study	0 - 60 months	The main efficacy variable was change in serum ferritin in response to therapy with ICL670. Due to variability of serum ferritin, end of study was considered as the mean of at most the last 3 available observations after the start of ICL670.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events After Start of ICL670	0 - 60 months	The primary analysis was on Safety Analysis Set which comprised all participants who received at least one dose of ICL670 during the core/extension phase of the study. All participants previously treated with ICL670/DFO for 52weeks in the core study.	participants	NUMBER
SECONDARY	Change in Serum Ferritin From Start of ICL670 to End of Study	0 - 60 months	The primary analysis was on Full Analysis Set which comprised all participants who received at least one dose of ICL670 during the core or the extension phase of the study. All participants previously treated with ICL670 or DFO for 52 weeks in the core study were eligible for enrollment.	µg/L	MEDIAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Adverse Events After Start of ICL670	ICL670	Adverse Events	131	10.66	participants
Number of Participants With Adverse Events After Start of ICL670	Crossover	Adverse Events	49	11.32	participants
Number of Participants With Adverse Events After Start of ICL670	ICL670	Deaths	1		participants
Number of Participants With Adverse Events After Start of ICL670	Crossover	Deaths	2		participants
Change in Serum Ferritin From Start of ICL670 to End of Study	ICL670		-245.5	Full Range -8701.3 to 7626.5	µg/L
Change in Serum Ferritin From Start of ICL670 to End of Study	Crossover		-134.3	Full Range -6124.0 to 5136.7	µg/L

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ICL670	132
Overall Study	STARTED	Crossover	53
Overall Study	COMPLETED	ICL670	43
Overall Study	COMPLETED	Crossover	19
Overall Study	NOT COMPLETED	ICL670	89
Overall Study	NOT COMPLETED	Crossover	34

Source ClinicalTrials.gov

Adverse events572

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
other	Leukocytosis	Blood and lymphatic system disorders	ICL670	4	132
other	Leukocytosis	Blood and lymphatic system disorders	Crossover	3	53
other	Lymphadenopathy	Blood and lymphatic system disorders	ICL670	8	132
other	Lymphadenopathy	Blood and lymphatic system disorders	Crossover	2	53
other	Tachycardia	Cardiac disorders	ICL670	2	132
other	Tachycardia	Cardiac disorders	Crossover	3	53
other	Sickle cell anaemia with crisis	Congenital, familial and genetic disorders	ICL670	37	132
other	Sickle cell anaemia with crisis	Congenital, familial and genetic disorders	Crossover	13	53
other	Ear pain	Ear and labyrinth disorders	ICL670	8	132
other	Ear pain	Ear and labyrinth disorders	Crossover	3	53

1 to 10 of 572Source ClinicalTrials.gov

See all 572 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ICL670
Total, all-cause mortality	Crossover
Total, other adverse events	ICL670	129	132
Total, other adverse events	Crossover	47	53
Total, serious adverse events	ICL670	97	132
Total, serious adverse events	Crossover	34	53

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons1

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

Comparison
ICL670 vs Crossover: serious adverse events

Source 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/NCT01090323

GET https://conductscience.org/api/trials/v1/NCT01090323/events?page=2

API reference For AI assistants