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
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    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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