Trial · NCT00600938
Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload
NCT00600938, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2014-08-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload. Trials, record NCT00600938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00600938
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload
- NCT number
- NCT00600938
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 197 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Transfusional Iron Overload, Transfusional Hemosiderosis
- Interventions
- Core Study: Deferasirox, Core Study: Deferoxamine, Extension: deferoxamine to deferasirox, Extension: deferasirox to deferoxamine, Deferasirox, Deferoxamine
- First posted
- 2008-01-25
- Last updated
- 2014-08-27
- Other registries' IDs
- eudract:2007-000766-20
- Results first posted
- 2014-08-27
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment | 12 Month | Non- inferiority in efficacy of deferasirox compared to deferoxamine (DFO) in treating cardiac iron overload as measured by T2\*. A non-inferiority margin of 0.9 (90%) was applied. Due to limitations in performing heart biopsies, T2\* (T2 star), a Magnetic Resonance (MR) relaxation parameter expressed in milliseconds, as is an important tool to noninvasively quantify cardiac iron concentration. Studies have shown that myocardial T2\* evaluations may predict cardiac events, e.g., impaired (\<56%) left ventricular ejection fraction (LVEF) is prevalent among patients with low T2\*: found in 62% of patients with T2\*\<8 ms; 20% with T2\* of 8-12 ms; and in 5% with T2\* \>12 ms (Tanner 2006) |
| Secondary | Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF) | 12 Month | An absolute change from baseline in LVEF after 12 months treatment with deferasirox and compared to.DFO was tested using an analysis of covariance model including baseline left ventricular ejection fraction (LVEF) as a covariate. |
| Secondary | Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF) | 6 Month | An absolute change from baseline in LVEF after 6 months treatment with deferasirox and DFO was summarized |
| Secondary | Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment | 6 Month | Summary statistics of T2\* ratio Month 6/baseline |
| Secondary | Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI) | 6 Month, 12 Month | An absolute change from baseline in LVESVI after 6 and 12 months treatment with deferasirox and DFO was summarized. Changes in cardiovascular magnetic resonance (CMR) measured left ventricular end systolic after 6 and 12 months treatment. Left ventricular (LV) end-systolic volume indexed to body surface area (ESVI) is a simple yet powerful echocardiographic marker of LV remodeling that can be measured easily. Left ventricular (LV) end-systolic volume (ESV) has been shown to be an important determinant of survival after myocardial infarction (MI) |
| Secondary | Core Study: Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI) | 6 Month, 12 Month | An absolute change from baseline in LVEDVI after 6, and 12 months treatment with deferasirox and DFO was summarized |
| Secondary | Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Mass Indices (LVMI) | 6 Month, 12 Month | An absolute change from baseline in LVMI after 6, and 12 months treatment with deferasirox and DFO was summarized |
| Secondary | Core Study: Cardiac Function and the Proportion of Patients Dropping Out Due to Cardiac Dysfunction After Treatment With Deferasirox vs. Deferoxamine | 12 Month | The number of patients withdrawn from the study due to LVEF \<50%, T2\* \<6 ms or significant decreases in T2\* ≥ 33% from baseline was provided per treatment group. |
| Secondary | Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period. | 12 Month | Number of patients with adverse events, serious adverse events and death |
| Secondary | Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Area Under the Plasma Concentration-time Curve for a Dosing Interval (AUCtau) | 12 Month | The plasma level of deferasirox (ICL670) obtained in this study was summarized descriptively. Plasma concentration was plotted by patient and by visit. Descriptive statistics included the mean, median, SD, and CV, min and max. deferasirox pharmacokinetics (PK) trough levels over the 12 months of treatment and obtained PK profiles for the 40 mg/kg/day deferasirox dose, area under the plasma concentration-time curve for a dosing interval (AUCtau) |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment | 12 Month | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2\* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations. | Millisecond | GEOMETRIC_MEAN |
| SECONDARY | Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF) | 12 Month | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2\* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF) | 6 Month | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2\* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Percent | MEAN |
| SECONDARY | Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment | 6 Month | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2\* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI) | 6 Month, 12 Month | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2\* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Milliliter | MEAN |
| SECONDARY | Core Study: Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Diastolic Volume Indices (LVEDVI) | 6 Month, 12 Month | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2\* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Percent | MEAN |
| SECONDARY | Core Study: Cardiac Function After 6 and 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Mass Indices (LVMI) | 6 Month, 12 Month | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2\* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | gram/m^2 | MEAN |
| SECONDARY | Core Study: Cardiac Function and the Proportion of Patients Dropping Out Due to Cardiac Dysfunction After Treatment With Deferasirox vs. Deferoxamine | 12 Month | Per Protocol Set (PPS) consisted of all randomized patients who received at least 6 months of randomized study drug, had a T2\* value assessed at least 150 days after randomization, adhered to the major inclusion and none of the major exclusion criteria, and had no major protocol deviations | Participants | NUMBER |
| SECONDARY | Core Study: Safety and Tolerability of Deferasirox vs Deferoxamine Over the 12 Months Treatment Period. | 12 Month | Safety Set (SS) consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. Treatment received is defined as first study drug administered | Participants | NUMBER |
| SECONDARY | Core Study: Single and Repeated Dose Pharmacokinetics of Deferasirox, Area Under the Plasma Concentration-time Curve for a Dosing Interval (AUCtau) | 12 Month | Pharmacokinetic Analysis Set (PAS): PAS 2: All randomized patients who received the same dose of deferasirox for at least four consecutive days prior to PK sample collection and completed PK sample collection specified in the protocol at Visit 3 or Visit 4 (pre-dose, 1, 2, and 4 hours post-dose). | (h.ng/mL) | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group167
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment | Core: Deferasirox (ICL) | 1.12 | 95% Confidence Interval 3.687 | Millisecond | |
| Core Study: Change From Baseline in Myocardial T2* (Magnetic Resonance T2-star (T2*) Technique for the Measurement of Tissue Iron) After 12 Months Treatment | Core: Deferoxamine (DFO) | 1.07 | 95% Confidence Interval 2.931 | Millisecond | |
| Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF) | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | -0.5 | Standard Error 0.47 | Percent | |
| Core Study: Cardiac Function After 12 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF) | Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO | -0.0 | Standard Error 0.49 | Percent | |
| Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF) | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | -0.95 | Standard Deviation 4.485 | Percent | |
| Core Study: Cardiac Function After 6 Months of Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular Ejection Fraction (LVEF) | Deferoxamine (DFO). For Extension Labeled as DFO to DFO | -0.37 | Standard Deviation 4.389 | Percent | |
| Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | 1.04 | 95% Confidence Interval 4.752 | Ratio | |
| Core Study: Change From Baseline in Myocardial T2* After 6 Months Treatment | Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 1.04 | 95% Confidence Interval 4.417 | Ratio | |
| Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI) | Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL | Change from baseline at 6 Month (n= 85, 73) | 1.8 | Standard Deviation 8.021 | Milliliter |
| Core Study: Cardiac Function After 6 and 12 Months Treatment With Deferasirox vs. Deferoxamine, by Change in Left Ventricular End Systolic Volume Indices (LVESVI) | Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO | Change from baseline at 6 Month (n= 85, 73) | 0.88 | Standard Deviation 8.919 | Milliliter |
1 to 10 of 167Source ClinicalTrials.gov
See all 167 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Study | STARTED | Deferasirox (ICL). For Extension Labeled as ICL to ICL | 98 | |
| Core Study | STARTED | Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 99 | |
| Core Study | STARTED | DFO to ICL (Deferoxamine to Deferasirox) | 0 | |
| Core Study | STARTED | ICL to DFO (Deferasirox to Deferoxamine) | 0 | |
| Core Study | Core Safety Set | Deferasirox (ICL). For Extension Labeled as ICL to ICL | 96 | |
| Core Study | Core Safety Set | Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 91 | |
| Core Study | Core Safety Set | DFO to ICL (Deferoxamine to Deferasirox) | 0 | |
| Core Study | Core Safety Set | ICL to DFO (Deferasirox to Deferoxamine) | 0 | |
| Core Study | Per Protocol Set (PPS) | Deferasirox (ICL). For Extension Labeled as ICL to ICL | 91 | |
| Core Study | Per Protocol Set (PPS) | Deferoxamine (DFO). For Extension Labeled as DFO to DFO | 81 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events528
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 | Thrombocytosis | Blood and lymphatic system disorders | Core Phase - ICL670 | 0 | 96 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Core Phase - DFO | 4 | 91 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Extension Phase - ICL to ICL | 1 | 73 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Extension Phase - DFO to DFO | 2 | 29 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Extension Phase - DFO to ICL | 2 | 42 | |
| other | Thrombocytosis | Blood and lymphatic system disorders | Extension Phase - ICL to DFO | 0 | 1 | |
| other | Hypogonadism | Endocrine disorders | Core Phase - ICL670 | 2 | 96 | |
| other | Hypogonadism | Endocrine disorders | Core Phase - DFO | 2 | 91 | |
| other | Hypogonadism | Endocrine disorders | Extension Phase - ICL to ICL | 0 | 73 | |
| other | Hypogonadism | Endocrine disorders | Extension Phase - DFO to DFO | 0 | 29 |
1 to 10 of 528Source ClinicalTrials.gov
See all 528 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Core Phase - ICL670 | ||
| Total, all-cause mortality | Core Phase - DFO | ||
| Total, all-cause mortality | Extension Phase - ICL to ICL | ||
| Total, all-cause mortality | Extension Phase - DFO to DFO | ||
| Total, all-cause mortality | Extension Phase - DFO to ICL | ||
| Total, all-cause mortality | Extension Phase - ICL to DFO | ||
| Total, other adverse events | Core Phase - ICL670 | 60 | 96 |
| Total, other adverse events | Core Phase - DFO | 58 | 91 |
| Total, other adverse events | Extension Phase - ICL to ICL | 56 | 73 |
| Total, other adverse events | Extension Phase - DFO to DFO | 19 | 29 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|
Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL vs Core; Deferoxamine (DFO). For Extension Labeled as DFO to DFO: Core Study: Cardiac Function and the Proportion of Patients Dropping Out Due to Cardiac Dysfunction After Treatment With Deferasirox vs. Deferoxamine |
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.
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/NCT00600938
GET https://conductscience.org/api/trials/v1/NCT00600938/registered?page=2