Last updated: 11/07/2018 19:41:02

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

GSK study ID
TPL104054
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects with Chronic Liver Disease Undergoing Elective Invasive Procedures
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Number of participants with chronic liver disease and thrombocytopenia (platelets <50 Gi/L) who do not require a platelet transfusion prior to, during, and up to 7 days following elective invasive procedures

Timeframe: Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26

Secondary outcomes:

Number of participants with a World Health Organization (WHO) bleeding score >=2 during and up to 7 days following elective invasive procedures

Timeframe: Prior to, during, and up to 7 days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26

Number of participants with the indicated number of platelet transfusions administered

Timeframe: Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26

Median platelet count at Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 day follow-up; early withdrawal; and maximum post-baseline

Timeframe: Screening; Days 1, 8, 15, 16-19; Procedure + 7, 14, 21, 30 day follow-up; early withdrawal; and maximum post-baseline

Number of participants with the indicated platelet count at Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 day follow-up (FU); and maximum post-baseline

Timeframe: Screening; Days 8 and 15; Procedure + 7, 14, 21, 30 day follow-up; and maximum post-baseline

Number of participants experiencing an adverse event (AEs) and serious adverse event (SAEs) within the indicated category

Timeframe: Screening to Procedure +30 day follow-up or early withdrawal

Number of participants with a serious adverse event that occurred in greater than one participant

Timeframe: Screening to Procedure +30 day follow-up or early withdrawal

Number of participants with the indicated event relating to vision

Timeframe: Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit)

Number of participants with renal function abnormality

Timeframe: Screening to Procedure +30 day follow-up or early withdrawal

Number of participants with a clinically significant change in electrocardiogram (ECG) results

Timeframe: Screening, Baseline, Day 15, and Withdrawal

Pharmacokinetics (PK) of eltrombopag, steady state AUC(0-tau)

Timeframe: Day 14

Pharmacokinetics (PK) of eltrombopag, Cmax

Timeframe: Day 14

Pharmacokinetics (PK) of eltrombopag, t1/2

Timeframe: Day 14

Pharmacokinetics (PK) of eltrombopag, CL/F

Timeframe: Day 14

Mean number of days spent in the hospital

Timeframe: Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26

Mean number of unscheduled office visits, unscheduled laboratory tests, and unscheduled procedures

Timeframe: Prior to, during, and up to 4 weeks (30 days) following elective invasive procedures (Days 16-19); therefore, this covers a time period from Baseline to Day 26

Interventions:
  • Drug: Eltrombopag
  • Drug: Placebo
  • Enrollment:
    292
    Primary completion date:
    2009-24-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    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;367:716-724
    Farrell C, Hayes SC, Wire M, Zhang J.Population pharmacokinetic/pharmacodynamic modelling of eltrombopag in healthy volunteers and subjects with chronic liver disease.Br J Clin Pharmacol.2014;77(3):532-44
    Medical condition
    non-alcoholic steatohepatitis, HCV, HIV Infection, Thrombocytopenia
    Product
    eltrombopag
    Collaborators
    Not applicable
    Study date(s)
    June 2008 to November 2009
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Male and female subjects, 18 years of age or more with chronic liver disease.
    • Child-Pugh score of 12 or less.
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Samara, Russia, 443011
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hershey, Pennsylvania, United States, 17033-0850
    Status
    Study Complete
    Location
    GSK Investigational Site
    Smolensk, Russia, 214006
    Status
    Study Complete
    Location
    GSK Investigational Site
    Villejuif, France, 94804
    Status
    Study Complete
    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35294-0005
    Status
    Study Complete
    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60637
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lahore, Pakistan, 54000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33125
    Status
    Study Complete
    Location
    GSK Investigational Site
    Paris Cedex 12, France, 75571
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ekaterinburg, Russia, 620102
    Status
    Study Complete
    Location
    GSK Investigational Site
    Taipei, Taiwan, 100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33136
    Status
    Study Complete
    Location
    GSK Investigational Site
    Milano, Lombardia, Italy, 20132
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nice, France, 06202
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wroclaw, Poland, 50-367
    Status
    Study Complete
    Location
    GSK Investigational Site
    San Giovanni Rotondo (FG), Puglia, Italy, 71013
    Status
    Study Complete
    Location
    GSK Investigational Site
    Oviedo, Spain, 33006
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Ciudad Autonoma de Buenos Aires, Argentina, 1264
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37232
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hospitalet de Llobregat, Spain, 08907
    Status
    Study Complete
    Location
    GSK Investigational Site
    Slupsk, Poland, 76-200
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28007
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rosario, Santa Fe, Argentina, S2002KDR
    Status
    Study Complete
    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28203
    Status
    Study Complete
    Location
    GSK Investigational Site
    Charleston, South Carolina, United States, 29425
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97239
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sevilla, Spain, 41013
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    San Francisco, California, United States, 94115
    Status
    Study Complete
    Location
    GSK Investigational Site
    Milano, Lombardia, Italy, 20122
    Status
    Study Complete
    Location
    GSK Investigational Site
    Washington, District of Columbia, United States, 20307
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACI
    Status
    Study Complete
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19140
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Torino, Piemonte, Italy, 10126
    Status
    Study Complete
    Location
    GSK Investigational Site
    Douliou, Taiwan, 640
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Burlington, Massachusetts, United States, 01805
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08035
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Lyon Cedex 02, France, 69288
    Status
    Study Complete
    Location
    GSK Investigational Site
    Clermont Ferrand Cédex 1, France, 63058
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Falls Church, Virginia, United States, 22046
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Lyon, France, 69437
    Status
    Study Complete
    Location
    GSK Investigational Site
    Incheon, South Korea, 400-711
    Status
    Study Complete
    Location
    GSK Investigational Site
    Paris, France, 75014
    Status
    Study Complete
    Location
    GSK Investigational Site
    Genova, Liguria, Italy, 16132
    Status
    Study Complete
    Location
    GSK Investigational Site
    Valencia, Spain, 46014
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lahore, Pakistan, 54600
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barakaldo, Spain, 48903
    Status
    Study Complete
    Location
    GSK Investigational Site
    Taipei, Taiwan, 112
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M6H 3M1
    Status
    Study Complete
    Location
    GSK Investigational Site
    Calgary, Alberta, Canada, T2N 4Z6
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Busan, South Korea, 614-735
    Status
    Study Complete
    Location
    GSK Investigational Site
    Derqui, Pilar, Buenos Aires, Argentina, B1629AHJ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mumbai, India, 400020
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Detroit, Michigan, United States, 48202
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Montreal, Québec, Canada, H2X 3J4
    Status
    Study Complete
    Location
    GSK Investigational Site
    Jaipur, India, 302004
    Status
    Study Complete
    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32224
    Status
    Study Complete
    Location
    GSK Investigational Site
    Roma, Lazio, Italy, 00168
    Status
    Study Complete
    Location
    GSK Investigational Site
    Napoli, Campania, Italy, 80123
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08003
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08025
    Status
    Study Complete
    Location
    GSK Investigational Site
    New York, New York, United States, 10021
    Status
    Study Complete
    Location
    GSK Investigational Site
    Roma, Lazio, Italy, 00133
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Bologna, Emilia-Romagna, Italy, 40138
    Status
    Study Complete
    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23249
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kaohsiung, Taiwan, 807
    Status
    Study Complete
    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27715
    Status
    Study Complete
    Location
    GSK Investigational Site
    Scottsdale, Arizona, United States, 85259
    Status
    Study Complete
    Location
    GSK Investigational Site
    Málaga, Spain, 29010
    Status
    Study Complete
    Location
    GSK Investigational Site
    Taoyuan, Taiwan
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Seoul, South Korea, 138-736
    Status
    Study Complete
    Location
    GSK Investigational Site
    Valencia, Spain, 46009
    Status
    Study Complete
    Location
    GSK Investigational Site
    Montpellier, France, 34295
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Milano, Lombardia, Italy, 20162
    Status
    Study Complete
    Location
    GSK Investigational Site
    Avellino, Campania, Italy, 83100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ottawa, Ontario, Canada, K1H 8L6
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Warszawa, Poland, 01-201
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saint-Petersburg, Russia, 194044
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Bari, Puglia, Italy, 70124
    Status
    Study Complete
    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205-7199
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21202
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lubin, Poland, 59-301
    Status
    Study Complete
    Location
    GSK Investigational Site
    Barcelona, Spain, 08036
    Status
    Study Complete
    Location
    GSK Investigational Site
    Edegem, Belgium, 2650
    Status
    Study Complete
    Location
    GSK Investigational Site
    Valladolid, Spain, 47012
    Status
    Study Complete
    Location
    GSK Investigational Site
    New Orleans, Louisiana, United States, 70112
    Status
    Study Complete
    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46202
    Status
    Study Complete
    Location
    GSK Investigational Site
    Palermo, Sicilia, Italy, 90127
    Status
    Study Complete
    Location
    GSK Investigational Site
    Boston, Massachusetts, United States, 02215
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28034
    Status
    Study Complete
    Location
    GSK Investigational Site
    San Diego, California, United States, 92103-8707
    Status
    Study Complete
    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23298
    Status
    Study Complete
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75235
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ann Arbor, Michigan, United States, 48109
    Status
    Study Complete
    Location
    GSK Investigational Site
    Padova, Veneto, Italy, 35128
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Marseille, France, 13385
    Status
    Study Complete
    Location
    GSK Investigational Site
    Capital Fefderal, Buenos Aires, Argentina
    Status
    Study Complete
    Location
    GSK Investigational Site
    Denver, Colorado, United States, 80262
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mumbai, India, 400 016
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Brussels, Belgium, 1070
    Status
    Study Complete
    Location
    GSK Investigational Site
    Charlottesville, Virginia, United States, 22908
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Paris Cedex 13, France, 75651
    Status
    Study Complete
    Location
    GSK Investigational Site
    Chorzow, Poland, 41-500
    Status
    Study Complete
    Location
    GSK Investigational Site
    Valhalla, New York, United States, 10595
    Status
    Study Complete
    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90048
    Status
    Study Complete

    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2009-24-11
    Actual study completion date
    2009-24-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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