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
Terminated (halted prematurely)
Terminated (halted prematurely)
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
Observational study model:
Not applicable
Primary completion date:
2009-24-11
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
Terminated (halted prematurely)
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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