Trial · NCT00171210
An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload
NCT00171210, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload. Trials, record NCT00171210. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00171210
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload
- NCT number
- NCT00171210
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 506 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Transfusional Iron Overload in β-thalassemia
- Interventions
- Deferasirox
- First posted
- 2005-09-15
- Last updated
- 2011-05-30
- Results first posted
- 2011-05-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | up to 5 years | Adverse events results are based on preferred terms with at least 7% of participants in any group. |
| Secondary | Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by Liver Biopsy | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Mean absolute change of LIC from start of Deferasirox (ICL670) treatment to the end of study assessed by liver biopsy. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw). |
| Secondary | Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by SQUID | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Mean absolute change in LIC from start of Deferasirox (ICL670) treatment to the end of the study assessed by Superconducting Quantum Interfering Device (SQUID) measurement used as a non-invasive alternative to Biopsy for pediatric participants. Reported in milligrams of Iron per gram dry weight (mg Fe/g dw). |
| Secondary | Long-term Effect of Treatment With ICL670 on the Changes in Serum Ferritin Levels From Start of ICL670 Treatment to End of Study | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Mean Absolute Change in serum ferritin (ug/L) from start of treatment with Deferasirox (ICL670) to end of study taking into account the therapeutic goal which will either be to maintain iron balance or to induce negative iron balance. End of study taken as the mean of, at most, the last three available results after start of treatment with ICL670. |
| Secondary | Change in Surrogate Marker: Serum Transferrin From Start of Treatment With ICL670 to End of Study | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Measurement of the relative change in percent of potential surrogate marker: Serum Transferrin (g/L) from start of treatment with Deferasirox (ICL670) to end of study. (Serum Transferrin at the End of Study-Serum Transferrin at Start of ICL670)/Serum Transferrin at Start of ICL670\*100. |
| Secondary | Change in Surrogate Marker: Serum Iron From Start of Treatment With ICL670 to End of Study | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Measurement of the relative change of potential surrogate markers: Serum Iron (µmol/L) from start of treatment with Deferasirox (ICL670) to end of study. (Serum Iron at the End of Study-Serum Iron at Start of ICL670)/Serum Iron at Start of ICL670\*100. |
| Secondary | Change in Surrogate Marker: Transferrin Saturation From Start of Treatment With ICL670 to End of Study | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Measurement of the relative change of potential surrogate marker: Transferrin Saturation (Percent) from start of treatment with Deferasirox (ICL670) to end of study. (Transferrin Saturation at the End of Study-Tranferrin Saturation at Start of ICL670)/Transferrin Saturation at Start of ICL670\*100. |
| Secondary | Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Measurement of median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through biopsy. Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw). |
| Secondary | Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Relative change in liver iron content (LIC) as measured by biopsy and calculated by: End of study value - Start of ICL670 treatment value (absolute change) / Start of ICL670 treatment value. |
| Secondary | Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by SQUID | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Measurement of the median absolute change in liver iron content (LIC) from start of treatment with Deferasirox (ICL670) to end of study obtained through Superconducting Quantum Interfering Device (SQUID). Absolute change = End of study value - start of treatment value. LIC is expressed in mg of iron per gram of liver dry weight (mg Fe/g dw). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | up to 5 years | All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. | Participants | NUMBER |
| SECONDARY | Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by Liver Biopsy | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study. | mg Fe/g dw | MEAN |
| SECONDARY | Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by SQUID | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study. | mg Fe/g dw | MEAN |
| SECONDARY | Long-term Effect of Treatment With ICL670 on the Changes in Serum Ferritin Levels From Start of ICL670 Treatment to End of Study | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. | μg/L | MEAN |
| SECONDARY | Change in Surrogate Marker: Serum Transferrin From Start of Treatment With ICL670 to End of Study | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. | Percent change | MEAN |
| SECONDARY | Change in Surrogate Marker: Serum Iron From Start of Treatment With ICL670 to End of Study | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. | Percent change | MEAN |
| SECONDARY | Change in Surrogate Marker: Transferrin Saturation From Start of Treatment With ICL670 to End of Study | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | All patients enrolled into core study and who consented to participate in extension contributed to the pool of data on long term safety follow-up. Analyses included all patients who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 patients from the core group who did not continue into extension. | Percent change | MEAN |
| SECONDARY | Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study. | mg Fe/g dw | MEDIAN |
| SECONDARY | Relative Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by Biopsy | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC Biopsy data at Start of ICL670 treatment and End of Study. | percent of start value | MEDIAN |
| SECONDARY | Absolute Change in Liver Iron Content From Start of ICL670 Treatment to End of Study Measured by SQUID | Start of ICL670 treatment, End of Study or study discontinuation (up to 5 years) | Population includes only those participants from the full analysis set (defined as all participants who received at least 1 dose of ICL670 in the core/extension study, that is, analyses also included ICL670 participants from the core group who did not continue into extension) and had LIC SQUID data at Start of ICL670 treatment and End of Study. | mg Fe/g dw | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | Crossover | Pyrexia | 109 | Participants | |
| Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | ICL670 | Pyrexia | 113 | Participants | |
| Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | Crossover | Cough | 85 | Participants | |
| Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | ICL670 | Cough | 110 | Participants | |
| Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | Crossover | Headache | 81 | Participants | |
| Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | ICL670 | Headache | 84 | Participants | |
| Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | Crossover | Diarrhoea | 73 | Participants | |
| Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | ICL670 | Diarrhoea | 69 | Participants | |
| Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | Crossover | Vomiting | 61 | Participants | |
| Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event | ICL670 | Vomiting | 75 | Participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crossover | 259 | |
| Overall Study | STARTED | ICL670 | 296 | |
| Overall Study | STARTED EXTENSION STUDY | Crossover | 259 | |
| Overall Study | STARTED EXTENSION STUDY | ICL670 | 247 | |
| Overall Study | COMPLETED | Crossover | 190 | |
| Overall Study | COMPLETED | ICL670 | 181 | |
| Overall Study | NOT COMPLETED | Crossover | 69 | |
| Overall Study | NOT COMPLETED | ICL670 | 115 |
Source ClinicalTrials.gov
Adverse events468
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 | Palpitations | Cardiac disorders | ICL670 | 17 | 296 | |
| other | Palpitations | Cardiac disorders | Crossover | 11 | 259 | |
| other | Ear pain | Ear and labyrinth disorders | ICL670 | 16 | 296 | |
| other | Ear pain | Ear and labyrinth disorders | Crossover | 14 | 259 | |
| other | Abdominal pain | Gastrointestinal disorders | ICL670 | 74 | 296 | |
| other | Abdominal pain | Gastrointestinal disorders | Crossover | 57 | 259 | |
| other | Abdominal pain upper | Gastrointestinal disorders | ICL670 | 51 | 296 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Crossover | 52 | 259 | |
| other | Constipation | Gastrointestinal disorders | ICL670 | 17 | 296 | |
| other | Constipation | Gastrointestinal disorders | Crossover | 13 | 259 |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 adverse eventsAdverse 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 | 266 | 296 |
| Total, other adverse events | Crossover | 236 | 259 |
| Total, serious adverse events | ICL670 | 102 | 296 |
| Total, serious adverse events | Crossover | 61 | 259 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21628399 | 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 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.
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/NCT00171210
GET https://conductscience.org/api/trials/v1/NCT00171210/results?page=2