The main purpose of this study is to compare the effect of tebapivat versus placebo on anemia and to detect a dose-response for hemoglobin (Hb) response in participants with SCD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
59
Oral tablets.
Oral tablets.
UConn Health
Farmington, Connecticut, United States
Percentage of Participants With Hb Response
Time frame: Baseline, Week 10 through Week 12
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 72
Average Change From Baseline in Hb Concentration
Time frame: Baseline, Week 10 through Week 12
Average Change From Baseline in Indirect Bilirubin
Time frame: Baseline, Week 10 through Week 12
Average Change From Baseline in Lactate Dehydrogenase (LDH)
Time frame: Baseline, Week 10 through Week 12
Average Change From Baseline in Absolute Reticulocyte Count
Time frame: Baseline, Week 10 through Week 12
Average Change From Baseline in Percent Reticulocytes
Time frame: Baseline, Week 10 through Week 12
Average Change From Baseline in Erythropoietin
Time frame: Baseline, Week 10 through Week 12
Average Change From Baseline in Patient Reported Outcomes Measurement Information System® (PROMIS) Fatigue 13a Short Form Score
Time frame: Baseline, Week 10 through Week 12
Average Change From Baseline in PROMIS Pain Intensity 1a Score
Time frame: Baseline, Week 10 through Week 12
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Emory-Children's Center/ Children's Healthcare of Atlanta: Arthur M. Blank Hospital
Atlanta, Georgia, United States
Henry Ford Health System
Detroit, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Prisma Health Cancer Institute - Farris Road
Greenville, South Carolina, United States
University of Texas Health Science Center of Houston
Houston, Texas, United States
Fred Hutchinson Cancer Center, University of Washington
Seattle, Washington, United States
...and 10 more locations
Average Change From Baseline in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Impact Score
Time frame: Baseline, Week 10 through Week 12
Plasma Concentration of Tebapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Week 8
Maximum (Peak) Concentration (Cmax) of Tebapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Week 8
Time to Cmax (tmax) of Tebapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Week 8
Area Under the Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t) of Tebapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Week 8
Whole Blood Concentrations of 2,3-Diphosphoglycerate (2,3-DPG)
Time frame: Pre-dose and at multiple timepoints post-dose up to Week 8
Whole Blood Concentrations of Adenosine Triphosphate (ATP)
Time frame: Pre-dose and at multiple timepoints post-dose up to Week 8