RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag
Public ClinicalTrials.gov record NCT00370331. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The rationale for this Phase III study is to evaluate the 6 month safety and efficacy of eltrombopag in the treatment of previously treated subjects with chronic ITP. The starting dose of eltrombopag, 50 mg, once daily was selected based upon the observed efficacy, safety and pharmacokinetics in a dose-finding Study (TRA100773). This Phase III study is a randomized, double-blind, placebo-controlled, Phase III study, to evaluate efficacy, safety and tolerability of eltrombopag, initially administered as 50 mg oral tablets once daily for six months in adult subjects with previously treated chronic ITP. Subjects will be randomized 2:1, eltrombopag to placebo, and will be stratified based upon splenectomy status, use of ITP medication at baseline and baseline platelet count less than or equal to 15,000/µL. Subjects will receive study medication for 6 months, during which the dose of study medication may be adjusted based upon individual platelet counts. In addition, subjects may taper off concomitant ITP medications and may receive any rescue treatments as dictated by local standard of care. After discontinuation of study medication, subjects will complete follow-up visits at weeks 1, 2, 4 and months 3 and 6.
Study identification
- NCT ID
- NCT00370331
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 197 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2006
- Primary completion
- Jun 30, 2008
- Completion
- Jun 30, 2008
- Last update posted
- Apr 17, 2017
2006 – 2008
United States locations
- U.S. sites
- 26
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Duarte | California | 91010 | — |
| GSK Investigational Site | Los Angeles | California | 90033 | — |
| GSK Investigational Site | San Francisco | California | 94143 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20010-2975 | — |
| GSK Investigational Site | Hollywood | Florida | 33021 | — |
| GSK Investigational Site | Atlanta | Georgia | 30341 | — |
| GSK Investigational Site | Savannah | Georgia | 31405 | — |
| GSK Investigational Site | Honolulu | Hawaii | 96813 | — |
| GSK Investigational Site | Boston | Massachusetts | 02114 | — |
| GSK Investigational Site | Worcester | Massachusetts | 01655 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | Buffalo | New York | 14215 | — |
| GSK Investigational Site | New York | New York | 10029 | — |
| GSK Investigational Site | New York | New York | 10065 | — |
| GSK Investigational Site | Cleveland | Ohio | 44106 | — |
| GSK Investigational Site | Lawton | Oklahoma | 73505 | — |
| GSK Investigational Site | Portland | Oregon | 97227 | — |
| GSK Investigational Site | Willow Grove | Pennsylvania | 19090 | — |
| GSK Investigational Site | Dallas | Texas | 75137 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | Lubbock | Texas | 79410 | — |
| GSK Investigational Site | Lubbock | Texas | 79415 | — |
| GSK Investigational Site | Arlington | Virginia | 22205 | — |
| GSK Investigational Site | Seattle | Washington | 98109 | — |
| GSK Investigational Site | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 89 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00370331, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 17, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00370331 live on ClinicalTrials.gov.