Status:
COMPLETED
Phase 2, Pharmacokinetics Study of Eltrombopag in Japanese Thrombocytopenic Subjects With Chronic Liver Disease
Lead Sponsor:
GlaxoSmithKline
Conditions:
Liver Diseases
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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)
- Has had a bilateral tubal ligation
- Is post-menopausal (demonstrate total cessation of menses for longer 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.
- 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).
- Subject has no physical limitation to ingest and retain oral medication.
Exclusion
- 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
- medication for hypertension or cancer
- Human Immunodeficiency Virus (HIV) infection.
- History of drug/alcohol abuse or dependence within 1 year prior to screening.
- Any disease condition associated with current active World Health Organization (WHO) Grade 3 or 4 bleeding.
- 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.
- History of porphyria.
- Subjects who are deemed unsuitable for the study by the investigator (or subinvestigator).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00861601
Start Date
January 1 2009
End Date
August 1 2009
Last Update
May 12 2015
Active Locations (10)
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1
GSK Investigational Site
Fukuoka, Japan, 810-8563
2
GSK Investigational Site
Fukuoka, Japan, 814-0180
3
GSK Investigational Site
Fukuoka, Japan, 815-8555
4
GSK Investigational Site
Fukuoka, Japan, 830-0011