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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00351468 |
An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/microL will be investigated.
Condition | Intervention | Phase |
---|---|---|
Idiopathic Thrombocytopenic Purpura |
Drug: eltrombopag olamine (SB-497115-GR) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study. |
Estimated Enrollment: | 200 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects are eligible for participation in this study if they were previously randomized to an ITP study of eltrombopag (e.g., TRA100773 or TRA102537/RAISE or TRA108057/REPEAT) and meet the inclusion and exclusion criteria in Section 5.2.1 and Section 5.2.2.
1.1.1. Inclusion Criteria
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
1.1.2. Other Eligibility Criteria Considerations To assess any potential impact on subject eligibility with regard to safety, the investigator must refer to the following document(s) for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the investigational product(s) being used in this study: CIB, SPM.
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | TRA105325 |
Study First Received: | July 10, 2006 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00351468 |
Health Authority: | United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
idiopathic thrombocytopenic purpura ITP thrombocytopenia |
platelets eltrombopag olamine SB-497115-GR |
Purpura Autoimmune Diseases Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemostatic Disorders Purpura, Thrombocytopenic |
Signs and Symptoms Thrombocytopathy Thrombocytopenia Hemorrhagic Disorders Thrombocytopenic purpura, autoimmune Purpura, Thrombocytopenic, Idiopathic |
Skin Manifestations Immune System Diseases |