11 results
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.
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…
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…
The primary objectives of the study are to compare the efficacy of CNTO1275 to Etanercept and evaluate the safety of CNTO1275 and Etanercept.The secondary objective of this study is to evaluate the efficacy and safety of retreatment with CNTO1275.
- 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…
To evaluate the performance of patients with dental implants that have been restored with CAD CAM 3D printed resin/polymer screw retained crowns on Straumann dental implants. As no clinical study has been carried out on these materials up till now…
To compare the effect of eltrombopag and IVIG on the achievement of the platelet count threshold before and after surgery.
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).
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