8 results
To compare the effect of eltrombopag and IVIG on the achievement of the platelet count threshold before and after surgery.
The objective of this trial is to investigate whether Eltrombopag added to standard immunosuppressive treatment increases the rate of early (at three months) complete response and blood counts and can be use as front-line therapy for SAA treatment.
To provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data.
Primary: To evaluate the efficacy of eltrombopag + cyclosporine as first-line therapy on overall hematologic response (neutrophil, platelet, hemoglobin) by 6 months.Secondary: Overall hematologic response (neutrophil, platelet, hemoglobin) by 3 and…
To characterize the PK of eltrombopag at steady state after oral administration in pediatric patients with SAA.Secondary (key only, see protocol page 40-41 for all objectives): Safety and tolerability. Efficacy (overall response rate ORR).
- To evaluate the relative bioavailability between the new eltrombopag capsule formulation (CPS) and the marketed tablet formulation (FCT) at single oral doses of 25 mg and 75 mg, in healthy subjects in the fasted state.- To evaluate the PK…
To investigate the effect of superior capsular reconstruction in patients with an irreparable degenerative rotator cuff tear on pain and function. Secondary, complications will be monitored and radiographic analyses performed as safety measures.
The co-primary endpoints of this study are PFS in intermediate and poor-risk subjects, as assessed by an Independent Radiology Review Committee (IRRC) and OS in intermediate and poor-risk subjects. The final analysis of PFS will occur after 583…