Myelofibrosis
Conditions
Brief summary
Proportion of participants with TI by the end of Week 24; defined as not requiring RBC transfusion (except in the case of clinically overt bleeding) for any ≥12-week interval.
Detailed description
Incidences of AEs, SAEs, and AEs leading to discontinuation., Clinically important changes in laboratory parameters (hematology, chemistry), vital signs, and ECOG performance status., Proportion of participants with TI at the end of Week 24; defined as not requiring RBC transfusion (except in the case of clinically overt bleeding) for ≥12 weeks preceding week 24, with all Hgb levels during the ≥12-week interval of ≥8 g/dL (except in the case of clinically overt bleeding)., Plasma concentration of Momelotinib and M21.
Interventions
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with TI by the end of Week 24; defined as not requiring RBC transfusion (except in the case of clinically overt bleeding) for any ≥12-week interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidences of AEs, SAEs, and AEs leading to discontinuation., Clinically important changes in laboratory parameters (hematology, chemistry), vital signs, and ECOG performance status., Proportion of participants with TI at the end of Week 24; defined as not requiring RBC transfusion (except in the case of clinically overt bleeding) for ≥12 weeks preceding week 24, with all Hgb levels during the ≥12-week interval of ≥8 g/dL (except in the case of clinically overt bleeding)., Plasma concentration of Momelotinib and M21. | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed