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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00678587 |
Purpose
The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.
| Condition | Intervention | Phase |
|---|---|---|
|
Thrombocytopenia Chronic Liver Disease Hepatitis C Virus HCV Hepatitis B Virus HBV Human Immunodeficiency Virus HIV Infection Non-alcoholic Steatohepatitis NASH. |
Drug: Placebo Drug: Eltrombopag |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active: Active Comparator
75 mg, once daily, oral
|
Drug: Eltrombopag
75 mg, once daily, oral
|
|
Placebo: Placebo Comparator
placebo, once daily, oral
|
Drug: Placebo
placebo, once daily, oral
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
Childbearing potential, has a negative urine and/or serum pregnancy test at screening, and within the 24 hour period prior to the first dose of investigational product and uses one of the following acceptable methods of contraception:
Exclusion Criteria:
Contacts and Locations
Show 114 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | TPL104054 |
| Study First Received: | May 13, 2008 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00678587 History of Changes |
| Health Authority: | European Union: European Medicines Agency; United States: Food and Drug Administration |
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thrombopoietin chronic liver disease-related thrombocytopenia platelets platelet transfusion elective invasive procedure. |
|
Liver Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Flaviviridae Infections Hepatitis, Viral, Human Fatty Liver Infection Hepadnaviridae Infections Thrombocytopenia Hepatitis B Hepatitis C Retroviridae Infections RNA Virus Infections |
Immune System Diseases Hematologic Diseases Blood Platelet Disorders Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases Hepatitis Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections |