Hemolysis Related Complications in SCD. A Phase II Study With Voxelotor

PHASE2UnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 22, 2023

Primary Completion Date

March 22, 2024

Study Completion Date

March 22, 2025

Conditions
Sickle Cell Disease
Interventions
DRUG

Voxelotor 1500 mg oral per day (GBT440) for 48 weeks in patients with sickle-cell disease

This is an open-label, single-arm, single-stage phase II trial of voxelotor in patients with sickle-cell disease. Voxelotor 500mg tablets. Voxelotor will be administered as 500mg tablets orally once daily. The participant should always take all 3 tablets in a row at the same time each day, unless the study doctor has instructed them to adjust the dose.

Trial Locations (1)

94010

RECRUITING

Hospital Henri Mondor, Créteil

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER