TerminatedNCT02274233Updated Sep 29, 2015

Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia

A Phase 1 interventional study of SP-420 in Iron Overload and Beta-Thalassemia, sponsored by Sideris Pharmaceuticals. Terminated at 7 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-29.

Sponsored by Sideris Pharmaceuticals · Phase 1, Interventional, and Treatment

Why this study was terminated

Changes in renal function parameters.

Phase: Phase 1
Study type: Interventional
Enrollment: 24
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Iron Overload
Beta-Thalassemia

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Keywords

Chelation
Iron Overload
Thalassemia
Transfusion
Iron Chelation

In context

Iron Overload

168 studies on the registry are indexed under Iron Overload; 8 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 108 interventional studies indexed under Iron Overload.

Browse Iron Overload studies →

Lead sponsor

This is the only study on the registry with Sideris Pharmaceuticals as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 criteria

Exclusion Criteria:

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 24 participants (actual)

Study arms

Experimental
1.5 mg/kg
1.5 mg/kg SP-420 once daily for 14 days
Drug: SP-420
Experimental
3 mg/kg
3 mg/kg SP-420 once daily for 14 days
Drug: SP-420
Experimental
6 mg/kg
6 mg/kg SP-420 once daily for 14 days
Drug: SP-420
Experimental
12 mg/kg
12 mg/kg SP-420 once daily for 14 days
Drug: SP-420
Experimental
24 mg/kg
24 mg/kg SP-420 once daily for 28 days
Drug: SP-420
Experimental
9 mg/kg
9 mg/kg SP-420 twice daily for 28 days
Drug: SP-420

Interventions

DrugSP-420

What researchers measure

Primary outcomes

Number of Participants with Adverse Events
Time frame: Up to 35 days

Secondary outcomes

Peak Plasma Concentration (Cmax) of SP-420
Time frame: Day 7
Area under the plasma concentration versus time curve (AUC) of SP-420
Time frame: Day 7

Study locations

7 sites

Sideris Investigative Site
Boston, Massachusetts 02115, United States
Sideris Investigative Site
New York, New York 10065, United States
Sideris Investigative Site
Philadelphia, Pennsylvania 19104, United States
Sideris Investigative Site
Toronto, Ontario M5G 2N2, Canada
Sideris Investigative Site
Beirut, Lebanon
Sideris Investigative Site
Bangkok, 10700, Thailand
Sideris Investigative Site
Izmir, 35100, Turkey (Türkiye)

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02274233
Lead sponsor: Sideris Pharmaceuticals
Responsible party: Sponsor
First posted: Oct 24, 2014
Start date: Oct 2014
Primary completion: Sep 2015
Completion: Sep 2015
Last update: Sep 29, 2015

Study contacts

Sideris Pharmaceuticals, Inc. Sideris Pharmaceuticals, Inc.

study director · Sideris Pharmaceuticals, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: SP-420

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