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

NCT ID: NCT00678587

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-10-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

placebo, once daily, oral

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo, once daily, oral

Active

75 mg, once daily, oral

Group Type: ACTIVE_COMPARATOR

Eltrombopag

Intervention Type: DRUG

75 mg, once daily, oral

Interventions

Eltrombopag

75 mg, once daily, oral

Intervention Type: DRUG

Placebo

placebo, once daily, oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

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

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Charlottesville, Virginia, United States

GSK Investigational Site

Falls Church, Virginia, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Capital Fefderal, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

Derqui, Pilar, Buenos Aires, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

GSK Investigational Site

Brussels, , Belgium

GSK Investigational Site

Edegem, , Belgium

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Ottawa, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Clermont Ferrand Cédex 1, , France

GSK Investigational Site

Lyon, , France

GSK Investigational Site

Lyon, , France

GSK Investigational Site

Marseille, , France

GSK Investigational Site

Montpellier, , France

GSK Investigational Site

Nice, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Paris, , France

GSK Investigational Site

Villejuif, , France

GSK Investigational Site

Jaipur, , India

GSK Investigational Site

Mumbai, , India

GSK Investigational Site

Mumbai, , India

GSK Investigational Site

Bari, Apulia, Italy

GSK Investigational Site

San Giovanni Rotondo (FG), Apulia, Italy

GSK Investigational Site

Avellino, Campania, Italy

GSK Investigational Site

Napoli, Campania, Italy

GSK Investigational Site

Bologna, Emilia-Romagna, Italy

GSK Investigational Site

Rome, Lazio, Italy

GSK Investigational Site

Rome, Lazio, Italy

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Turin, Piedmont, Italy

GSK Investigational Site

Palermo, Sicily, Italy

GSK Investigational Site

Padua, Veneto, Italy

GSK Investigational Site

Lahore, , Pakistan

GSK Investigational Site

Lahore, , Pakistan

GSK Investigational Site

Chorzów, , Poland

GSK Investigational Site

Lubin, , Poland

GSK Investigational Site

Słupsk, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Samara, , Russia

GSK Investigational Site

Smolensk, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

GSK Investigational Site

Busan, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Barakaldo, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

L'Hospitalet de Llobregat, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Madrid, , Spain

GSK Investigational Site

Málaga, , Spain

GSK Investigational Site

Oviedo, , Spain

GSK Investigational Site

Seville, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valencia, , Spain

GSK Investigational Site

Valladolid, , Spain

GSK Investigational Site

Douliu, , Taiwan

GSK Investigational Site

Kaohsiung City, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taoyuan District, , Taiwan

Countries

United States; Argentina; Belgium; Canada; France; India; Italy; Pakistan; Poland; Russia; South Korea; Spain; Taiwan

References

Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D; ELEVATE Study Group. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. N Engl J Med. 2012 Aug 23;367(8):716-24. doi: 10.1056/NEJMoa1110709.

Reference Type: DERIVED

PMID: 22913681 (View on PubMed)

Other Identifiers

TPL104054

Identifier Type: -

Identifier Source: org_study_id