13 results
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…
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…
Primary aim of the study is to evaluate the efficacy and safety of intramuscular magnesiumsulphate in CRPS I patients during 3 weeks dose escalation study.
To test this hypothesis by administering inhaled isotonic magnesium sulphate to patients with stable severe asthma and persistent airflow obstruction (postbronchodilator FEV1 < 75% predicted) and determine the bronchodilating effect by…
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…
In patients undergoing cardiothoracic surgery, to investigate the effect of continuous (preceded by a bolus) administration of perioperative magnesium sulphate (MgSO4) on the incidence patients with POAF.
Primary objective: To explore the effect on volume of keloid tissue (mm3), measured by 3D-camera, after three consecutive treatments with electronic jet injector assisted bleomycin delivery, compared with placebo in a split-lesion design.Secondary…
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