Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00424177 |
This open-label, repeat dosing study, TRA108057, will evaluate the efficacy, safety and tolerability of eltrombopag, when administered in a repeat, cyclic dosing schedule. The study will describe the effect of repeated (3 cycles), intermittent dosing of eltrombopag on the pharmacodynamics and durability of eltrombopag response as measured by the peripheral platelet counts.
For more information or to see if you qualify, please visit: http://www.itpstudy.com/gov
Condition | Intervention | Phase |
---|---|---|
Chronic Idiopathic Thrombocytopenic Purpura |
Drug: eltrombopag |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP) |
Enrollment: | 66 |
Study Start Date: | March 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
eltrombopag: Experimental |
Drug: eltrombopag
experimental
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
It is important to clearly differentiate the effect of eltrombopag on platelet count from the treatment effects of prior and concomitant ITP therapies. Therefore:
Complete abstinence from intercourse; Intrauterine device (IUD); Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); Male partner is sterile prior to entry into the study and is the only partner of the female; Systemic contraceptives (combined or progesterone only). Subject is able to understand and comply with protocol requirements and instructions and intends to complete the study as planned.
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | TRA108057 |
Study First Received: | January 17, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00424177 |
Health Authority: | United States: Food and Drug Administration; United States: Food and Drug Administration |
idiopathic thrombocytopenic purpura ITP thrombocytopenia platelets |
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 |