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NCT01186419 · ClinicalTrials.gov registry record · Phase 2
Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload
A Phase 2 study of Beta-Thalassemia and Transfusional Iron Overload, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 9
- Study locations
NCT01186419: Completed Phase 2 study of Beta-Thalassemia and Transfusional Iron Overload, sponsored by Shire.
NCT01186419 is a Phase 2 study of Beta-Thalassemia and Transfusional Iron Overload that has completed, run by Shire. The registered enrollment target is 51 participants, below the 177-participant average among 14 other Beta-Thalassemia trials with a reported enrollment target (71% lower). The trial reports 9 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01186419, a Phase 2 study of Beta-Thalassemia and Transfusional Iron Overload, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
LIC was determined by R2 Magnetic Resonance Imaging (MRI).
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 |
What the finished NCT01186419 record still lists
NCT01186419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 177-participant average among 14 other Beta-Thalassemia trials with a reported enrollment target (71% lower).
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.
NCT01186419 lists 9 locations in 3 states (Other, California, Massachusetts).
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.
What interventions are being tested in trial NCT01186419?
The interventions under investigation include: SPD602 (FBS0701, SSP-004184) (DRUG).
Who is sponsoring clinical trial NCT01186419?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01186419's enrollment target sits among peer trials
51 7th of 14 higher than 8 of 14 other Beta-Thalassemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Beta-Thalassemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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