Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis, Chronic Liver Disease, HCV, NASH - Nonalcoholic Steatohepatitis, HIV Infection, Thrombocytopenia, Hepatitis C Virus, HBV, Human Immunodeficiency Virus, Liver Diseases, Hepatitis B Virus

In brief

The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.

Key facts

Study ID

NCT00678587

Run by

GlaxoSmithKline

People needed

292

Starts

2008-06-01

Expected to finish

2009-10-01

Last updated by the study team

2018-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects, 18 years of age or more with chronic liver disease.
• Child-Pugh score of 12 or less.
• Model of End Stage Liver Disease (MELD) score of 24 or less.
• Subjects who, in the opinion of the investigator, are appropriate candidates to undergo an elective invasive procedure and who require a platelet transfusion to manage the risk of bleeding associated with the procedure.
• A baseline platelet count <50,000/µL.
• A baseline serum sodium level >130mEq/L.
• Haemoglobin concentration >8g/dL stable for at least one month.
• 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 (either combined or progesterone only).
• Any other contraceptive method with a documented failure rate of <1% per year.
• Subject has no physical limitation to ingest and retain oral medication.
• Subject is able to understand and comply with protocol requirements and instructions and is likely to complete the study as planned.
• Subject is able to provide signed and dated written informed consent.
• In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

You may not qualify if…

• Subjects with a known 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.
• Any disease condition associated with current active WHO Grade 3 or 4 bleeding.
• Active infection requiring systemic antibiotic therapy. Prophylactic use of antibiotics is permitted.
• Pregnant or nursing women.
• 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.
• Previous participation in TPL104054.

Where it is running

• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Burlington, Massachusetts, United States
• GSK Investigational Site — Ann Arbor, Michigan, United States
• GSK Investigational Site — Detroit, Michigan, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Valhalla, New York, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Hershey, Pennsylvania, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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