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Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease
This study is currently recruiting participants.
Verified by GlaxoSmithKline, April 2009
First Received: March 5, 2009   Last Updated: April 30, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00861601
  Purpose

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

MedlinePlus related topics: Liver Diseases
Drug Information available for: Eltrombopag
U.S. FDA Resources
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To evaluate the effects of eltrombopag on platelet count when administered once daily for 2 weeks to subjects with thrombocytopenia and chronic liver disease (platelets <50,000/mcL) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of eltrombopag when administered once daily for 2 weeks to thrombocytopenic subjects with chronic liver disease [ Designated as safety issue: Yes ]
  • To describe the pharmacokinetics (PK) of eltrombopag and explore the relationship between the PK and PD (safety and platelet counts) [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 (See Appendix 2).
  • A baseline platelet count <50,000/mcL.
  • A baseline serum sodium level >130mEq/L.
  • Haemoglobin concentration >8g/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)
  • Has had a bilateral tubal ligation
  • Is post-menopausal (demonstrate total cessation of menses for greater than one year) 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:
  • Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical study, and for 28 days after completion or premature discontinuation from the study to account for the elimination of the study drug (minimum of 5 half-lives).
  • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.
  • Double-barrier contraception (condom with spermicidal jelly, or diaphragm with spermicide).
  • Male partner who is sterile (diagnosed by a qualified medical professional) prior to the female subject's study entry and is the sole sexual partner for that female.
  • Oral contraceptive (combined).
  • Any other contraceptive method with a documented failure rate of <1% per year.
  • Subject has no physical limitation to ingest and retain oral medication.*

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 MRI/CT imaging techniques) within 3 months of study start.*
  • History of arterial or venous thrombosis (including Budd-Chiari Syndrome),*

AND ≥ two of the following risk factors*:

  • hereditary thrombophilic disorders (e.g. Factor V Leiden, ATIII deficiency, etc.)
  • hormone replacement therapy
  • systemic contraception therapy (containing oestrogen)
  • smoking
  • diabetes
  • hypercholesterolemia
  • medication for hypertension or cancer
  • HIV infection.*
  • History of drug/alcohol abuse or dependence within 1 year prior to screening.*
  • Any disease condition associated with current active WHO Grade 3 or 4 bleeding (See Appendix 3).
  • Active infection requiring systemic antibiotic therapy. **
  • Pregnant, nursing mothers, women who may be pregnant, or women who plan to become pregnant during the time of study participation.
  • Treatment with platelet transfusion within 2 weeks prior to Day 1.
  • Treatment with interferon within 4 weeks prior to Day 1.
  • Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
  • History of platelet agglutination abnormality that prevents reliable measurement of platelet counts.*
  • History of porphyria.*
  • Subjects who are deemed unsuitable for the study by the investigator (or subinvestigator).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861601

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

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

Study placed in the following topic categories:
Thrombocytopathy
Liver Diseases
Digestive System Diseases
Thrombocytopenia
Hematologic Diseases
Blood Platelet Disorders

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Thrombocytopenia
Hematologic Diseases
Blood Platelet Disorders

ClinicalTrials.gov processed this record on May 07, 2009