Loading clinical trials...

COMPLETEDPHASE2

Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease

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

NCT00861601•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject who agree to comply with protocol requirements and instructions and who provide signed and dated written informed consent.
•Male and female subjects, ≥20 years of age (at the time of informed consent) with chronic liver disease.
•Child-Pugh score \<=9.
•A baseline platelet count \<50,000/mcL.
•A baseline serum sodium level \>130 mEq/L.
•Haemoglobin concentration \>8 g/dL, stable for at least 4 weeks.
•A female is eligible to enter and participate in the study if she is of:
•Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
•Has had a hysterectomy
•Has had a bilateral oophorectomy (ovariectomy)
+9 more criteria

Exclusion Criteria

•Subjects with known or suspected hypersensitivity, intolerance or allergy to any of the ingredients in eltrombopag tablets.
•Evidence of portal vein thrombosis on abdominal imaging (ultrasound with Doppler or appropriate magnetic resonance imaging/computed tomography (MRI/CT) imaging techniques) within 3 months before the start of the study.
•History of arterial or venous thrombosis (including Budd-Chiari Syndrome),
•AND ≥ two of the following risk factors:
•hereditary thrombophilic disorders (e.g. antithrombinIII (ATIII) deficiency, etc.)
•hormone replacement therapy
•systemic contraception therapy (containing oestrogen)
•smoking
•diabetes
•hypercholesterolemia
+12 more criteria

Locations (10)

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Kagoshima, Japan

GSK Investigational Site

Kumamoto, Japan

GSK Investigational Site

Kumamoto, Japan

GSK Investigational Site

Nagasaki, Japan

GSK Investigational Site

Ōita, Japan

Key Dates

Start Date

January 1, 2009

Primary Completion Date

August 1, 2009

Completion Date

August 1, 2009

Last Updated

May 12, 2015

Enrollment

ACTUAL participants

Conditions

Liver Diseases

Interventions

eltrombopag 12.5 milligrams (mg) tablet

DRUG

eltrombopag 25 mg tablet

DRUG

MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease

NCT05264051

Liver Diseases

View study

RECRUITINGNA

Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

NCT06493773

Liver Diseases, AlcoholicAlcohol Use Disorder+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 12, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease

Inclusion Criteria

Exclusion Criteria

MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease

Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial

The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose

Design and Implementation of the Pediatric Liver Transplantation Biobank

Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation