A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease
Phase 3
408
about 4.1 years
12+
49 sites in AL, AR, AZ +24
What this study is about
Researchers are testing whether etavopivat reduces the number of vaso-occlusive crises (sickle cell pain crises) caused by blood vessel blockages in adults and adolescents with sickle cell disease. The trial will also evaluate how well etavopivat can reduce organ damage, improve exercise tolerance, and decrease fatigue in people with sickle cell disease. Participants will either receive etavopivat or a placebo. Which treatment they get is decided randomly. Etavopivat is a new medicine being tested in other studies as well.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Etavopivat
- 2.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Secondary: Change in distance travelled during the 6-minute walking test (6MWT), Change in standardised T-score on the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Scale, Participants achieving the threshold for clinically meaningful change (yes/no) in 6MWT, Participants achieving the threshold for clinically meaningful change (yes/no) in PROMIS fatigue scale 7a