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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274233
Recruitment Status : Terminated (Changes in renal function parameters.)
First Posted : October 24, 2014
Last Update Posted : September 29, 2015
Sponsor:
Information provided by (Responsible Party):
Sideris Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE October 24, 2014
Last Update Posted Date September 29, 2015
Study Start Date  ICMJE October 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2014)		 Number of Participants with Adverse Events [ Time Frame: Up to 35 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia
Official Title  ICMJE Multicenter, Open-label, Dose-escalation Study of SP-420 in Subjects With Transfusion-dependent β-Thalassemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Iron Overload
  • Beta-Thalassemia
Intervention  ICMJE Drug: SP-420
Study Arms  ICMJE
  • Experimental: 1.5 mg/kg
    1.5 mg/kg SP-420 once daily for 14 days
    Intervention: Drug: SP-420
  • Experimental: 3 mg/kg
    3 mg/kg SP-420 once daily for 14 days
    Intervention: Drug: SP-420
  • Experimental: 6 mg/kg
    6 mg/kg SP-420 once daily for 14 days
    Intervention: Drug: SP-420
  • Experimental: 12 mg/kg
    12 mg/kg SP-420 once daily for 14 days
    Intervention: Drug: SP-420
  • Experimental: 24 mg/kg
    24 mg/kg SP-420 once daily for 28 days
    Intervention: Drug: SP-420
  • Experimental: 9 mg/kg
    9 mg/kg SP-420 twice daily for 28 days
    Intervention: Drug: SP-420
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 22, 2014)		 24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Lebanon,   Thailand,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02274233
Other Study ID Numbers  ICMJE SP-420-702
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sideris Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sideris Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sideris Pharmaceuticals, Inc. Sideris Pharmaceuticals, Inc. Sideris Pharmaceuticals, Inc.
PRS Account Sideris Pharmaceuticals
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP