Trial · NCT01186419
Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload
NCT01186419, Phase 2, Completed, Shire; results first posted 2015-06-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload. Trials, record NCT01186419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01186419
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload
- NCT number
- NCT01186419
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Shire
- Conditions
- Transfusional Iron Overload, Beta-thalassemia
- Interventions
- SPD602 (FBS0701, SSP-004184)
- First posted
- 2010-08-23
- Last updated
- 2021-06-10
- Other registries' IDs
- eudract:2010-019645-25
- Results first posted
- 2015-06-03
- Limitations and caveats
Only data from all subjects (ie, total) are presented because dose adjustments that occurred after Week 24 obviated the meaningful interpretation of data presented by the original 16 and 32 mg/kg/day dose groups.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks | Baseline and 96 weeks | LIC was determined by R2 Magnetic Resonance Imaging (MRI). |
| Secondary | Maximum Plasma Concentration (Cmax) of SPD602 | 92 weeks | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered. |
| Secondary | Area Under The Steady-state Plasma Concentration-time Curve (AUC) of SPD602 | 92 weeks | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks | Baseline and 96 weeks | Full Analysis Set, defined as all subjects in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all subjects who received any amount of investigational product. | mg/g | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of SPD602 | 92 weeks | Pharmacokinetic (PK) Analysis Set, defined as all subjects in the Safety Set for whom the primary PK data were considered sufficient and interpretable. The Safety Set was defined as all subjects who received any amount of investigational product. | ng/ml | MEAN |
| SECONDARY | Area Under The Steady-state Plasma Concentration-time Curve (AUC) of SPD602 | 92 weeks | PK Analysis Set, defined as all subjects in the Safety Set for whom the primary PK data were considered sufficient and interpretable. The Safety Set was defined as all subjects who received any amount of investigational product. | ng*hr/ml | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks | SPD602 | -1.75 | Standard Deviation 4.839 | mg/g | |
| Maximum Plasma Concentration (Cmax) of SPD602 | SPD602 | 25702.7 | Standard Deviation 4448.06 | ng/ml | |
| Area Under The Steady-state Plasma Concentration-time Curve (AUC) of SPD602 | SPD602 | 62998.6 | Standard Deviation 23094.72 | ng*hr/ml |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SPD602 16 mg/kg/Day | 24 | |
| Overall Study | STARTED | SPD602 32 mg/kg/Day | 27 | |
| Overall Study | COMPLETED | SPD602 16 mg/kg/Day | 17 | |
| Overall Study | COMPLETED | SPD602 32 mg/kg/Day | 18 | |
| Overall Study | NOT COMPLETED | SPD602 16 mg/kg/Day | 7 | |
| Overall Study | NOT COMPLETED | SPD602 32 mg/kg/Day | 9 |
Source ClinicalTrials.gov
Adverse events130
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 | SPD602 16 mg/kg/d | 2 | 24 | 2 |
| other | Palpitations | Cardiac disorders | SPD602 32 mg/kg/d | 3 | 27 | 4 |
| other | Conjunctivitis | Eye disorders | SPD602 16 mg/kg/d | 2 | 24 | 2 |
| other | Conjunctivitis | Eye disorders | SPD602 32 mg/kg/d | 2 | 27 | 2 |
| other | Ocular icterus | Eye disorders | SPD602 16 mg/kg/d | 0 | 24 | 0 |
| other | Ocular icterus | Eye disorders | SPD602 32 mg/kg/d | 3 | 27 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | SPD602 16 mg/kg/d | 0 | 24 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | SPD602 32 mg/kg/d | 5 | 27 | 5 |
| other | Abdominal pain upper | Gastrointestinal disorders | SPD602 16 mg/kg/d | 4 | 24 | 4 |
| other | Abdominal pain upper | Gastrointestinal disorders | SPD602 32 mg/kg/d | 5 | 27 | 7 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD602 16 mg/kg/d | ||
| Total, all-cause mortality | SPD602 32 mg/kg/d | ||
| Total, other adverse events | SPD602 16 mg/kg/d | 24 | 24 |
| Total, other adverse events | SPD602 32 mg/kg/d | 26 | 27 |
| Total, serious adverse events | SPD602 16 mg/kg/d | 3 | 24 |
| Total, serious adverse events | SPD602 32 mg/kg/d | 2 | 27 |
Source ClinicalTrials.gov
Papers4
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 |
|---|
| SPD602 16 mg/kg/d vs SPD602 32 mg/kg/d: 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/NCT01186419
GET https://conductscience.org/api/trials/v1/NCT01186419/events?page=2