10 results
This study aims to provide evidence for the notion that reduction of spasticity by bilateral BTX injections in the hip adductor group followed by self-administered stretching exercises and agility training improves lateral stepping and gait…
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.
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 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 compare the effect of eltrombopag and IVIG on the achievement of the platelet count threshold before and after surgery.
- 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…
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…
Primary Objective:- Number of participants with dose limiting toxicity - Number of participants with treatment-related adverse events - Number of participants with treatment-emergent adverse events- Number of participants with changes in vital signs…
Primary (Parts 1 and 2)• To evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] by investigator) of 2 dose levels of tarlatamab Primary (Part 3)Evaluate safety of reduced mandatory monitoring…
Monotherapy (Parts A, B*, D, E, F and G)Primary Objectives - Evaluate the safety and tolerability of Tarlatamab - Part A only: Determine the MTD or RP2D of Tarlatamab Secondary Objectives• Evaluate preliminary anti-tumor activity of Tarlatamab •…