Anemia associated with myeloproliferative neoplasm (MPN)-associated myelofibrosis (MF)
Conditions
Brief summary
The Primary end point of RBC-transfusion is defined as the proportion of subjects who become RBC transfusion free during any consecutive 12-week period
Detailed description
The key secondary endpoint, defined as the proportion of subjects who become RBC-transfusion free over any consecutive 16-week period starting during the Blinded Core Treatment Period (the time from randomization up to and including Week 24) and referred to as RBC-TI 16..., .....will be tested in the same manner as the primary efficacy endpoint once superiority ofluspatercept on the primary endpoint is demonstrated.
Interventions
DRUG0.9 % w/v Sodium Chloride Injection
Sponsors
Celgene Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary end point of RBC-transfusion is defined as the proportion of subjects who become RBC transfusion free during any consecutive 12-week period | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary endpoint, defined as the proportion of subjects who become RBC-transfusion free over any consecutive 16-week period starting during the Blinded Core Treatment Period (the time from randomization up to and including Week 24) and referred to as RBC-TI 16..., .....will be tested in the same manner as the primary efficacy endpoint once superiority ofluspatercept on the primary endpoint is demonstrated. | — |
Countries
Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Romania, Spain
Outcome results
None listed