12 results
Part 1 (open-label, 8 week): safety and tolerability of eltrombopag, optimal dose escalation scheme for use in Part 2, PK.Part 2: Primary: the reduction in the number of clinically relevant thrombocytopenic events (*Grade 3 hemorrhagic adverse…
To assess the effect of Caphosol® oral rinse on clinical outcomes of selected oral symptom burden (oral mucositis/stomatitis (aphthous-like), oral pain, taste change (dysgeusia), difficulty swallowing (dysphagia), difficulty oral intake, and dry…
Core StudyPrimary objective• To compare the efficacy of E5501 (in addition to standard of care) to eltrombopag (in addition to standard of care) for the treatment of adult subjects with chronic immune thrombocytopenia (idiopathic thrombocytopenic…
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.
Objective: To investigate the safety and efficacy of a therapy consisting Everolimus and corticosteroids maintenance immunosuppressive regime twelve months after renal transplantation in recipients of donor kidney graft on graft function and acute…
Objectives: A prospective, open label, randomized trial, in which we aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy,…
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…
The purpose of this study is to assess the efficacy and safety of ianalumab (VAY736) compared to placebo in addition to second-line eltrombopag in adults with primary immune thrombocytopenia