Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia
Stopped early · Phase 1
Conditions studied: Iron Overload, Beta-Thalassemia
In brief
The purpose of this study is to assess safety and amount of the study drug in the blood after increasing doses of SP-420. The study will be conducted in patients with β-thalassemia.
Key facts
- Study ID
- NCT02274233
- Run by
- Sideris Pharmaceuticals
- People needed
- 24
- Starts
- 2014-10-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2015-09-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject has iron-overload secondary to β-thalassemia requiring chronic red blood cell transfusions and iron chelation therapy
- Subject weighs ≥35 kg
- Subject is willing to discontinue current iron chelation therapy at least 7 days prior to the first dose of SP-420 and for the duration of the study
- Serum ferritin ≥700 ng/mL and iron saturation ≥70% within 3 weeks before Baseline (Day 1)
- Cardiac T2* score >20 msec within 6 months before Baseline (Day 1)
- Willing to use contraception during the study
You may not qualify if…
- Pregnant or breast-feeding
- Serum creatinine greater than the upper limit of normal
- Platelet count <100 × 10\^9/L
- Use of another investigational drug within the last 30 days
- Significant cardiac, renal, hepatic dysfunction or other clinically significant conditions that, in the opinion of the Investigator, would exclude the subject
Where it is running
- Sideris Investigative Site — Boston, Massachusetts, United States
- Sideris Investigative Site — New York, New York, United States
- Sideris Investigative Site — Philadelphia, Pennsylvania, United States
- Sideris Investigative Site — Toronto, Ontario, Canada
- Sideris Investigative Site — Beirut, Lebanon
- Sideris Investigative Site — Bangkok, Thailand
- Sideris Investigative Site — Izmir, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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