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Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00861601 |
This is an open label, multi-centre, dose ranging study to assess efficacy, safety and pharmacokinetics of eltrombopag in thrombocytopenic subjects with chronic liver disease.
Condition | Intervention | Phase |
---|---|---|
Thrombocytopenia |
Drug: eltrombopag 25mg tablet Drug: eltrombopag 12.5mg tablet |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | TPL111913, a Multi-Centre, Open Label, Dose Ranging Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease |
Estimated Enrollment: | 36 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
middle dose: Experimental
eltrombopag 25mg / day
|
Drug: eltrombopag 25mg tablet
eltrombopag 25mg tablet once a day
|
low dose: Experimental
eltrombopag 12.5mg / day
|
Drug: eltrombopag 12.5mg tablet
eltrombopag 12.5mg tablet once a day
|
high dose: Experimental
eltrombopag 37.5mg / day
|
Drug: eltrombopag 25mg tablet
eltrombopag 25mg tablet once a day
Drug: eltrombopag 12.5mg tablet
eltrombopag 12.5mg tablet once a day
|
Ages Eligible for Study: | 20 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:
Exclusion Criteria:
AND ≥ two of the following risk factors*:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Japan | |
GSK Investigational Site | Recruiting |
Fukuoka, Japan, 830-0011 | |
GSK Investigational Site | Recruiting |
Oita, Japan, 879-5593 | |
GSK Investigational Site | Not yet recruiting |
Fukuoka, Japan, 810-8563 | |
GSK Investigational Site | Not yet recruiting |
Fukuoka, Japan, 815-8555 | |
GSK Investigational Site | Recruiting |
Fukuoka, Japan, 839-0863 | |
GSK Investigational Site | Recruiting |
Nagasaki, Japan, 856-8562 | |
GSK Investigational Site | Not yet recruiting |
Kumamoto, Japan, 860-8556 | |
GSK Investigational Site | Recruiting |
Kumamoto, Japan, 862-8655 | |
GSK Investigational Site | Not yet recruiting |
Fukuoka, Japan, 814-0180 | |
GSK Investigational Site | Not yet recruiting |
Kagoshima, Japan, 890-8520 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111913 |
Study First Received: | March 5, 2009 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00861601 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Thrombocytopathy Liver Diseases Digestive System Diseases |
Thrombocytopenia Hematologic Diseases Blood Platelet Disorders |
Liver Diseases Digestive System Diseases Thrombocytopenia Hematologic Diseases Blood Platelet Disorders |