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This study is a double-blind, randomized, placebo-controlled, parallel group, repeat-dose, study conducted in two parts (Part A and Part B) examining 30, 50, and 75 mg doses of SB-497115-GR as a treatment for patients with ITP who have failed prior therapy. The study is designed to determine the proportion of patients with a platelet count =50,000/µL after 42 days. In Part B, 99 newly-recruited subjects will be randomized to one of two dosing arms in a 2:1 ratio of active:placebo. During the 6 week study period, subjects will start on placebo or active drug (50 mg) and may have a dose increase to 75 mg based upon their platelet count at day 22.
A double-blind, randomized, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of SB-497119-GR, a thrombopoietin receptor agonist, administered at 30, 50, and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenia purpura
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB497115 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment response, assessed by the proportion of patients with platelet counts of =50, 000/µL (compared with baseline count of <30, 000/µL) after 42 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, tolerability, PK, PD, symptoms associated with ITP, and QoL, odds of response vs placebo during weeks 2 to 6 of the study. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bad Nauheim | Hesse | 61231 | Germany | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18046028 | Background | Bussel JB, Cheng G, Saleh MN, Psaila B, Kovaleva L, Meddeb B, Kloczko J, Hassani H, Mayer B, Stone NL, Arning M, Provan D, Jenkins JM. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med. 2007 Nov 29;357(22):2237-47. doi: 10.1056/NEJMoa073275. | |
| 20663993 | Background | Gibiansky E, Zhang J, Williams D, Wang Z, Ouellet D. Population pharmacokinetics of eltrombopag in healthy subjects and patients with chronic idiopathic thrombocytopenic purpura. J Clin Pharmacol. 2011 Jun;51(6):842-56. doi: 10.1177/0091270010375427. Epub 2010 Jul 27. |
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| Athens |
| 10676 |
| Greece |
| GSK Investigational Site | Athens | Greece |
| GSK Investigational Site | Thessaloniki | 57010 | Greece |
| GSK Investigational Site | Pokfulam | Hong Kong |
| GSK Investigational Site | Shatin | Hong Kong |
| GSK Investigational Site | Auckland | 1701 | New Zealand |
| GSK Investigational Site | Lahore | 54600 | Pakistan |
| GSK Investigational Site | Lodz | 93-510 | Poland |
| GSK Investigational Site | Bucharest | 022328 | Romania |
| GSK Investigational Site | Bucharest | 050098 | Romania |
| GSK Investigational Site | Moscow | 105 229 | Russia |
| GSK Investigational Site | Moscow | 125167 | Russia |
| GSK Investigational Site | Novosibirsk | 630087 | Russia |
| GSK Investigational Site | Ljubljana | 1000 | Slovenia |
| GSK Investigational Site | Maribor | 2000 | Slovenia |
| GSK Investigational Site | Seoul | 136-705 | South Korea |
| GSK Investigational Site | Seoul | 138-736 | South Korea |
| GSK Investigational Site | Seoul | 140-743 | South Korea |
| GSK Investigational Site | Taipei | 114 | Taiwan |
| GSK Investigational Site | Bangkok | 10330 | Thailand |
| GSK Investigational Site | Chiang Mai | 50000 | Thailand |
| GSK Investigational Site | Khon Kaen | 40002 | Thailand |
| GSK Investigational Site | Reading | Berkshire | RG1 7AN | United Kingdom |
| GSK Investigational Site | Taunton | Somerset | TA1 5DA | United Kingdom |
| GSK Investigational Site | Liverpool | L7 8XP | United Kingdom |
| GSK Investigational Site | London | E1 1BB | United Kingdom |
| GSK Investigational Site | London | WC1E 6HX | United Kingdom |
| GSK Investigational Site | Manchester | M13 9WL | United Kingdom |
| GSK Investigational Site | Swansea | SA6 6NL | United Kingdom |
| 23492914 | Derived | Tarantino MD, Fogarty P, Mayer B, Vasey SY, Brainsky A. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. Blood Coagul Fibrinolysis. 2013 Apr;24(3):284-96. doi: 10.1097/MBC.0b013e32835fac99. |
| 19231632 | Derived | Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L, Salama A, Jenkins JM, Roychowdhury D, Mayer B, Stone N, Arning M. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):641-8. doi: 10.1016/S0140-6736(09)60402-5. |
| ID | Term |
|---|---|
| D011693 | Purpura |
| C537560 | Jacobs syndrome |
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D011696 | Purpura, Thrombocytopenic |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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