Sickle cell disease
Conditions
Brief summary
Number of adjudicated VOC events with a medical contact.
Detailed description
Change in Hb >1 g/dL (yes/no), Time to onset of first adjudicated VOC., Change in standardised T-score on the PROMIS Fatigue 7a Scale., Change in haemoglobin (Hb), Change in lactate dehydrogenase (LDH), Change in absolute reticulocyte count, Change in indirect bilirubin, Change in distance travelled during the 6-minute walking test (6MWT), Participants achieving the threshold for clinically meaningful change (yes/no) in PROMIS fatigue scale 7a, Participants achieving the threshold for clinically meaningful change (yes/no) in 6MWT
Interventions
DRUGPlacebo
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adjudicated VOC events with a medical contact. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Hb >1 g/dL (yes/no), Time to onset of first adjudicated VOC., Change in standardised T-score on the PROMIS Fatigue 7a Scale., Change in haemoglobin (Hb), Change in lactate dehydrogenase (LDH), Change in absolute reticulocyte count, Change in indirect bilirubin, Change in distance travelled during the 6-minute walking test (6MWT), Participants achieving the threshold for clinically meaningful change (yes/no) in PROMIS fatigue scale 7a, Participants achieving the threshold for clinically meaningful change (yes/no) in 6MWT | — |
Countries
Belgium, France, Greece, Italy, Netherlands, Spain
Outcome results
None listed