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Result Summaries: eltrombopag

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Study ID
   Phase    Title Summary (Download)
102860 phase 1 A Two-Part, Randomized, Placebo-Controlled Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Single, Oral Doses of the Thrombopoietin Receptor Agonist, Eltrombopag; and the Effect of Eltrombopag on Cardiac Repolarization as Compared to Placebo and Single Oral Doses of Moxiflo (0 citation(s)) Click here to download result summary.
102861 phase 1 An Open-Label Mass Balance Study to Investigate the Metabolic Disposition of a Single Oral Dose of 14C SB-497115-GR in Healthy Male Subjects. (1 citation(s)) Click here to download result summary.
102863 Phase 1 An open-label, randomized, five-period, period-balanced, crossover study to assess the effect of food and antacid on the pharmacokinetics of a single dose of SB-497115-GR (eltrombopag) in healthy volunteers (0 citation(s)) Click here to download result summary.
104603 phase 1 : Phase I Study of SB-497115-GR – Single Oral Dose Study in Healthy Japanese Male Subjects – (0 citation(s)) Click here to download result summary.
104631 phase 1 An open-label, randomized, five-period, period-balanced, crossover study to assess the effect of food and antacid on the pharmacokinetics of a single dose of SB-497115-GR (eltrombopag) in healthy volunteers (0 citation(s)) Click here to download result summary.
105120 phase 1 An Open-label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Rosuvastatin when Co-administered with Eltrombopag (SB-497115-GR) in Healthy Adult Subjects (1 citation(s)) Click here to download result summary.
105122 Phase 1 Phase I Bioequivalence Study for SB-497115-GR Phase II and Phase III Tablets (0 citation(s)) Click here to download result summary.
105580 phase 1 Phase I Study of SB-497115-GR - Single and Multiple Oral Dose Study in Healthy Japanese Male Subjects - <Clinical Pharmacology Study> (1 citation(s)) Click here to download result summary.
108109 phase 3 Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) -A Multicenter Study in Subjects with Chronic ITP Receiving a Double-Blind, Placebo-Controlled, Short-Term Treatment Followed by an Open-Label, Uncontrolled, Long-Term Treatment (1 citation(s)) Click here to download result summary.
111433 phase 3 Clinical Evaluation of eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An extension study of eltrombopag in subjects, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study TRA108109 (NCT00540423)-<Phase III Study> (0 citation(s)) Click here to download result summary.
111716 phase 1 A Phase I, Open-label, Single Sequence, Crossover Study Evaluating the Safety and the Pharmacokinetics of Lopinavir/Ritonavir and Eltrombopag Given Alone and when Co-administered in Healthy Adult Subjects. (1 citation(s)) Click here to download result summary.
111718 phase 1 A randomized-open-label-five-period-balanced-crossover study to evaluate the relative bioavailability of an eltrombopag PfOS formulation relative to the 25 mg tablet formulation and to evaluate administration of the PfOS formulation with and separated 2 hours from a high calcium meal in HV (1 citation(s)) Click here to download result summary.
111913 Phase 2 TPL111913, a Multi-centre, Open Label, Dose Ranging Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Eltrombopag in Japanese Thrombocytopenic Subjects with Chronic Liver Disease (0 citation(s)) Click here to download result summary.
112509 phase 1 Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects with Advanced Myelodysplastic Syndrome (MDS) or secondary Acute Myeloid Leukemia after MDS (sAML/MDS) (1 citation(s)) Click here to download result summary.
113918 phase 4 Cost Analysis of Thrombocytopenia Treatment in Patients with Chronic Immune (Idiopathic) Thrombocytopenic Purpura (0 citation(s)) Click here to download result summary.
113922 phase 4 Outcomes Comparison of Chronic Immune Thrombocytopenic Purpura (ITP) Patients Switched to Eltrombopag and Romiplostim (0 citation(s)) Click here to download result summary.
114013 n\a Systematic review of the clinical and cost effectiveness of treatments for idiopathic (immune) thrombocytopenic purpura (ITP): direct meta analysis (1 citation(s)) Click here to download result summary.
114014 n\a Indirect Comparison of efficacy of treatments for idiopathic immune thrombocytopenic purpura - review of platelet responses and bleeding events (1 citation(s)) Click here to download result summary.
114397 n\a Documentation of Factor V Leiden R506Q and prothrombin 20210G>A risk variants in chronic idiopathic thrombocytopaenic purpura (ITP) and chronic liver disease (CLD) patients experiencing thrombotic/thromboembolic events (TEE) during clinical studies with eltrombopag (0 citation(s)) Click here to download result summary.
116010 phase 1 A Phase I, Open-label, Three-Period, Single Sequence, Crossover Study Evaluating the Drug-Drug Interaction Between Eltrombopag and Boceprevir and Between Eltrombopag and Telaprevir in Healthy Adult Subjects (0 citation(s)) Click here to download result summary.
116344 n\a PGx471: Combined pharmacogenetic analysis of IL28B genotypes in TPL108390 and TPL103922 (0 citation(s)) Click here to download result summary.
116684 n\a PGX6115: Genetic Effects on Different eltrombopag Exposure between Asians and Whites (0 citation(s)) Click here to download result summary.
497115/003 phase 2 A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Assess the Efficacy, Safety, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist(SB497115-GR) Administered at 50, 75, and 100 mg to Cancer Patients Receiving Multiple Cycles of Chemotherapy (1 citation(s)) Click here to download result summary.
TPL102357 phase 2 A Double-Blind, Randomized, Placebo-Controlled, Multi-Centre, Dose-Ranging, Parallel Group, Phase II Study to Assess Efficacy, Safety/Tolerability, and Pharmacokinetics of a Thrombopoietin Receptor Agonist, SB-497115-GR, when Administered as 30, 50, and 75 mg Once Daily for 12 weeks in Subjects with (1 citation(s)) Click here to download result summary.
TPL103922 phase 3 Randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2a plus ribavirin (0 citation(s)) Click here to download result summary.
TPL104054 phase 3 Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects with Chronic Liver Disease Undergoing Elective Invasive Procedures (1 citation(s)) Click here to download result summary.
TPL108390 phase 3 Randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of eltrombopag in thrombocytopenic subjects with hepatitis C virus (HCV) infection who are otherwise eligible to initiate antiviral therapy (peginterferon alfa-2b plus ribavirin) (0 citation(s)) Click here to download result summary.
TRA100773 phase 2 See Detailed Description (3 citation(s)) Click here to download result summary.
TRA100773_B phase 3 A double-blind, randomized, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of SB-497115-GR, a thrombopoietin receptor agonist, administered at 30, 50 and 75 mg as oral tablets once-daily for 6 weeks to adult male and (3 citation(s)) Click here to download result summary.
TRA102537 phase 3 A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic ITP. (4 citation(s)) Click here to download result summary.
TRA103452 phase 1 An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral dose of 50mg Eltrombopag in Healthy Subjects and in Volunteers with Mild, Moderate or Severe Hepatic Impairment (1 citation(s)) Click here to download result summary.
TRA104412 phase 1 An Open-Label, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral Dose of 50 mg [SB-497115] in Healthy Subjects and in Subjects with Mild, Moderate, or Severe Renal Impairment (1 citation(s)) Click here to download result summary.
TRA106914 phase 1 A phase I, double-blind, placebo and observer-blind positive controlled, randomized, parallel group study in healthy subjects to investigate the photoirritant potential of eltrombopag (1 citation(s)) Click here to download result summary.
TRA108057 phase 2 An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) (3 citation(s)) Click here to download result summary.
TRC105499 phase 1 An Open-label, Dose Ranging Study to Assess the Safety, Efficacy, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (Eltrombopag) Administered to Subjects Receiving Adriamycin and Ifosfamide (AI) Regimen (0 citation(s)) Click here to download result summary.