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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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low dose

eltrombopag 12.5 mg/day

Group Type EXPERIMENTAL

eltrombopag 12.5 milligrams (mg) tablet

Intervention Type DRUG

eltrombopag 12.5 mg tablet once a day

middle dose

eltrombopag 25 mg/day

Group Type EXPERIMENTAL

eltrombopag 25 mg tablet

Intervention Type DRUG

eltrombopag 25 mg tablet once a day

high dose

eltrombopag 37.5 mg/day

Group Type EXPERIMENTAL

eltrombopag 12.5 milligrams (mg) tablet

Intervention Type DRUG

eltrombopag 12.5 mg tablet once a day

eltrombopag 25 mg tablet

Intervention Type DRUG

eltrombopag 25 mg tablet once a day

Interventions

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eltrombopag 12.5 milligrams (mg) tablet

eltrombopag 12.5 mg tablet once a day

Intervention Type DRUG

eltrombopag 25 mg tablet

eltrombopag 25 mg tablet once a day

Intervention Type DRUG

Eligibility Criteria

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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)
* 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 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
* 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).

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No