A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)
NCT06924970 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59
Last updated 2026-04-23
Summary
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.
Conditions
Interventions
- DRUG
-
Tebapivat
Oral tablets.
- DRUG
-
Tebapivat Matched Placebo
Oral tablets.
Sponsors & Collaborators
-
Agios Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2026-05-31
- Completion
- 2027-05-31
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Canada
- France
- Ireland
- Netherlands
- United Kingdom
Study Locations
More Related Trials
-
A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sickle Cell Disease
NCT04055818 ·Status: RECRUITING ·Phase: PHASE1
-
Decitabine for High-Risk Sickle Cell Disease
NCT01375608 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease
NCT03132324 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants
NCT05036512 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
NCT04624659 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease
NCT05725902 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease
NCT06198712 ·Status: RECRUITING ·Phase: PHASE2
-
Pharmacokinetics, Pharmacodynamics and Safety of Epeleuton in Patients With Sickle Cell Disease
NCT05861453 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Decitabine and Tetrahydrouridine (THU) in Patients With Sickle Cell Disease
NCT01685515 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
NCT06546670 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia
NCT06609226 ·Status: RECRUITING ·Phase: PHASE3
-
The Effect of Rivaroxaban in Sickle Cell Disease
NCT02072668 ·Status: COMPLETED ·Phase: PHASE2
-
The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease
NCT06975865 ·Status: RECRUITING ·Phase: PHASE3
-
Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling
NCT06313398 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
NCT01848925 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of SHP655 (rADAMTS13) in Sickle Cell Disease
NCT03997760 ·Status: COMPLETED ·Phase: PHASE1
-
Hydroxyurea in the Treatment of Sickle Cell Disease
NCT02709681 ·Status: COMPLETED
-
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
NCT05031780 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
Dose-Escalation Study of SCD-101 in Sickle Cell Disease
NCT02380079 ·Status: UNKNOWN ·Phase: PHASE1
-
N-Acetylcysteine in Patients With Sickle Cell Disease
NCT01849016 ·Status: COMPLETED ·Phase: PHASE3
-
AB1 in Adult Patients with Sickle Cell Disease (SCD)
NCT05261711 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A GBT021601 ADME Microtracer Study in Healthy Volunteers
NCT05718687 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of Different Dose Regimens of Aes-103 Given for 28 Days to Subjects With Stable Sickle Cell Disease
NCT01987908 ·Status: TERMINATED ·Phase: PHASE2
-
TRF-1101 Assessment in Sickle Cell Disease
NCT00773890 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease
NCT06578507 ·Status: RECRUITING ·Phase: PHASE2