Status:
TERMINATED
Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia
Lead Sponsor:
Sideris Pharmaceuticals
Conditions:
Iron Overload
Beta-Thalassemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02274233
Start Date
October 1 2014
End Date
September 1 2015
Last Update
September 29 2015
Active Locations (7)
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1
Sideris Investigative Site
Boston, Massachusetts, United States, 02115
2
Sideris Investigative Site
New York, New York, United States, 10065
3
Sideris Investigative Site
Philadelphia, Pennsylvania, United States, 19104
4
Sideris Investigative Site
Toronto, Ontario, Canada, M5G 2N2