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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

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.

• 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).