Trial · NCT00395629
Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis
NCT00395629, Phase 1, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2011-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis. Trials, record NCT00395629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00395629
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis
- NCT number
- NCT00395629
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 49 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Iron Overload, Hereditary Hemochromatosis
- Interventions
- Deferasirox (ICL670)
- First posted
- 2006-11-03
- Last updated
- 2011-05-30
- Other registries' IDs
- eudract:2006-002102-57
- Results first posted
- 2011-05-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population) | 0 to 48 weeks | Mean absolute change in serum ferritin from baseline to the end of the extension study. |
| Secondary | Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) | 4, 8, 12, 16, 20, and 24 weeks | A blood sample was collected just prior to administration of the next dose of Deferasirox (pre-dose trough level) or approximately 24 hours after the previous dose at weeks 4, 8, 12, 16, 20 and 24. The mean trough concentration at each time point was calculated. |
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 | Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population) | 0 to 48 weeks | Extension Per-protocol population including all participants of the per protocol population who also were part of the extension safety population. | µg/L | MEAN |
| SECONDARY | Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) | 4, 8, 12, 16, 20, and 24 weeks | Per-protocol population included all participants of the safety population; who received at least one dose of study drug within the core study and had at least one safety assessment, and who did not have any major protocol deviation. n in each of the Categories is the number of participants in each arm/group who had data for that time point. | µmol/L | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population) | Deferasirox (ICL670) 5 mg/kg/Day | -389.1 | Standard Deviation 185.35 | µg/L | |
| Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population) | Deferasirox (ICL670) 10 mg/kg/Day | -610.5 | Standard Deviation 341.84 | µg/L | |
| Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population) | Deferasirox (ICL670) 15 mg/kg/Day | -571.6 | Standard Deviation 552.81 | µg/L | |
| Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) | Deferasirox (ICL670) 5 mg/kg/Day | Week 4 (n=10,14,17) | 9.63 | Standard Deviation 8.783 | µmol/L |
| Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) | Deferasirox (ICL670) 10 mg/kg/Day | Week 4 (n=10,14,17) | 19.62 | Standard Deviation 9.502 | µmol/L |
| Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) | Deferasirox (ICL670) 15 mg/kg/Day | Week 4 (n=10,14,17) | 30.48 | Standard Deviation 20.201 | µmol/L |
| Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) | Deferasirox (ICL670) 5 mg/kg/Day | Week 8 (n=10,12,17) | 8.86 | Standard Deviation 5.828 | µmol/L |
| Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) | Deferasirox (ICL670) 10 mg/kg/Day | Week 8 (n=10,12,17) | 23.88 | Standard Deviation 22.787 | µmol/L |
| Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) | Deferasirox (ICL670) 15 mg/kg/Day | Week 8 (n=10,12,17) | 27.06 | Standard Deviation 21.686 | µmol/L |
| Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) | Deferasirox (ICL670) 5 mg/kg/Day | Week 12 (n=10,12,13) | 10.58 | Standard Deviation 11.752 | µmol/L |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Study | STARTED | Deferasirox (ICL670) 5 mg/kg/Day | 11 | |
| Core Study | STARTED | Deferasirox (ICL670) 10 mg/kg/Day | 15 | |
| Core Study | STARTED | Deferasirox (ICL670) 15 mg/kg/Day | 23 | |
| Core Study | COMPLETED | Deferasirox (ICL670) 5 mg/kg/Day | 10 | |
| Core Study | COMPLETED | Deferasirox (ICL670) 10 mg/kg/Day | 11 | |
| Core Study | COMPLETED | Deferasirox (ICL670) 15 mg/kg/Day | 16 | |
| Core Study | NOT COMPLETED | Deferasirox (ICL670) 5 mg/kg/Day | 1 | |
| Core Study | NOT COMPLETED | Deferasirox (ICL670) 10 mg/kg/Day | 4 | |
| Core Study | NOT COMPLETED | Deferasirox (ICL670) 15 mg/kg/Day | 7 | |
| Extension Study | STARTED | Deferasirox (ICL670) 5 mg/kg/Day | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events678
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 | Arrhythmia | Cardiac disorders | Deferasirox (ICL670) 5 mg/kg/day_Core Study | 1 | 11 | |
| other | Arrhythmia | Cardiac disorders | Deferasirox (ICL670) 10 mg/kg/day_Core Study | 0 | 15 | |
| other | Arrhythmia | Cardiac disorders | Deferasirox (ICL670) 15 mg/kg/day_Core Study | 0 | 23 | |
| other | Arrhythmia | Cardiac disorders | Deferasirox (ICL670) 5 mg/kg/day_Extension Study | 1 | 9 | |
| other | Arrhythmia | Cardiac disorders | Deferasirox (ICL670) 10 mg/kg/day_Extension Study | 0 | 6 | |
| other | Arrhythmia | Cardiac disorders | Deferasirox (ICL670) 15 mg/kg/day_Extension Study | 0 | 11 | |
| other | Atrioventricular block first degree | Cardiac disorders | Deferasirox (ICL670) 5 mg/kg/day_Core Study | 0 | 11 | |
| other | Atrioventricular block first degree | Cardiac disorders | Deferasirox (ICL670) 10 mg/kg/day_Core Study | 0 | 15 | |
| other | Atrioventricular block first degree | Cardiac disorders | Deferasirox (ICL670) 15 mg/kg/day_Core Study | 0 | 23 | |
| other | Atrioventricular block first degree | Cardiac disorders | Deferasirox (ICL670) 5 mg/kg/day_Extension Study | 0 | 9 |
1 to 10 of 678Source ClinicalTrials.gov
See all 678 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Deferasirox (ICL670) 5 mg/kg/day_Core Study | ||
| Total, all-cause mortality | Deferasirox (ICL670) 10 mg/kg/day_Core Study | ||
| Total, all-cause mortality | Deferasirox (ICL670) 15 mg/kg/day_Core Study | ||
| Total, all-cause mortality | Deferasirox (ICL670) 5 mg/kg/day_Extension Study | ||
| Total, all-cause mortality | Deferasirox (ICL670) 10 mg/kg/day_Extension Study | ||
| Total, all-cause mortality | Deferasirox (ICL670) 15 mg/kg/day_Extension Study | ||
| Total, other adverse events | Deferasirox (ICL670) 5 mg/kg/day_Core Study | 10 | 11 |
| Total, other adverse events | Deferasirox (ICL670) 10 mg/kg/day_Core Study | 14 | 15 |
| Total, other adverse events | Deferasirox (ICL670) 15 mg/kg/day_Core Study | 23 | 23 |
| Total, other adverse events | Deferasirox (ICL670) 5 mg/kg/day_Extension Study | 9 | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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 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.
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/NCT00395629
GET https://conductscience.org/api/trials/v1/NCT00395629/results?page=2