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Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload
NCT01186419 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new oral iron chelator, and its effectiveness in clearing iron from the liver. FBS0701 is a medication taken by mouth that causes the body to get rid of iron. Iron chelators are used in patients with β-thalassemia and other forms of anemia who experience iron overload - iron increases in the body as a result of regularly required blood transfusions. Patients who qualify will be randomized to receive one of two doses of FBS0701 for up to 24 weeks (6 months) with a total study duration of up to 33 weeks. These patients will be eligible to participate in a dosing extension for up to 72 weeks. The maximum duration of dosing will be up to 96 weeks. The safety of patients will be monitored frequently during the study by physical exams, ECGs, and blood tests. To assess the amount of iron in the liver and heart, each patient must undergo 6 MRI scans during the study. Patients will not need to stay in the hospital for this study but will need to visit the outpatient clinic up to 28 times over the 96 week period. Patients currently taking an iron chelator will be required to stop for a total of up to 26 weeks. The results of this study will help to determine if FBS0701 may be effective as an iron chelator.
Conditions Studied
Interventions
- DRUG SPD602 (FBS0701, SSP-004184)
Study Locations (9)
Other
- Ospedale Regionale Microcitemie — Cagliari
- Centro della Microcitemia e delle Anemie Congenite — Genoa
- Thalassemia Center San Luigi Hospital — Orbassano
- Siriraj Hospital, Mahidol University — Bangkok
- Pediatric Hematology, Ege University Hospital — Izmir
- University College London Hospital — London
- Whittington Hospital — London
California
- Children's Hospital and Research Center of Oakland — Oakland
Massachusetts
- Children's Hospital of Boston — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2010-08-13 |
| Est. Completion | 2013-01-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01186419
The ClinicalTrials.gov registry entry for NCT01186419 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Beta-thalassemia appearing as the primary indexed condition, and to 1 intervention — of which SPD602 (FBS0701, SSP-004184) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01186419 reports 9 study locations spanning 3 distinct geographic areas — top geographies include Other, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01186419 about?
NCT01186419 is a clinical study titled "Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload". The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new oral iron chelator, and its effectiveness in clearing iron from the liver. FBS0701 is a medication taken by mouth that causes the body to get rid of iron. Iron chelators are used in patients with β-thalassemi...
What is the current status of trial NCT01186419?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2010-08-13. Estimated completion is 2013-01-08.
What conditions does trial NCT01186419 study?
This clinical trial studies the following conditions: Beta-thalassemia, Transfusional Iron Overload. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01186419?
The interventions under investigation include: SPD602 (FBS0701, SSP-004184) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01186419?
This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01186419 being conducted?
This trial has 9 study locations across California, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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