NCT04610866View on ClinicalTrials.gov

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

December 9, 2020

Primary Completion Date

February 28, 2028

Study Completion Date

February 28, 2028

Conditions
Sickle Cell DiseaseHemolytic Anemia
Interventions
DRUG

Mitapivat

Investigational drug mitapivat (also known as AG-348, AGI-1480 and AGX-0841) is an orally bioavailable, broad-spectrum allosteric activator of alleles of the RBC-specific form of pyruvate kinase (PKR), as well as liver-type pyruvate kinase (PKL) and muscle pyruvate kinase (PKM1 and PKM2).

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH