Non-alcoholic SteatohepatitisPhase 3ELEVATENCT00678587
Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures
A Phase 3 study testing Eltrombopag in people with Non-alcoholic Steatohepatitis and Chronic Liver Disease, run by GlaxoSmithKline at 107 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-alcoholic Steatohepatitis, Chronic Liver Disease, HCV
- What is being tested?
- Eltrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 107 sitesin 13 countries
- Study dates
- Jun 2008to Oct 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 24Show fewer
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
107 sites in 13 countries.
107 sites in 13 countries
United States33 sites
GSK Investigational Site
Ann Arbor, Michigan, 48109
GSK Investigational Site
Baltimore, Maryland, 21202
GSK Investigational Site
Birmingham, Alabama, 35294-0005
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Burlington, Massachusetts, 01805
GSK Investigational Site
Charleston, South Carolina, 29425
GSK Investigational Site
Charlotte, North Carolina, 28203
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Dallas, Texas, 75235
GSK Investigational Site
Denver, Colorado, 80262
GSK Investigational Site
Detroit, Michigan, 48202
GSK Investigational Site
Durham, North Carolina, 27715
GSK Investigational Site
Falls Church, Virginia, 22046
GSK Investigational Site
Hershey, Pennsylvania, 17033-0850
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Jacksonville, Florida, 32224
GSK Investigational Site
Little Rock, Arkansas, 72205-7199
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Miami, Florida, 33125
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Nashville, Tennessee, 37232
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
Portland, Oregon, 97239
GSK Investigational Site
Richmond, Virginia, 23249
GSK Investigational Site
Richmond, Virginia, 23298
GSK Investigational Site
San Diego, California, 92103-8707
GSK Investigational Site
San Francisco, California, 94115
GSK Investigational Site
Scottsdale, Arizona, 85259
GSK Investigational Site
Valhalla, New York, 10595
GSK Investigational Site
Washington D.C., District of Columbia, 20307
Italy14 sites
GSK Investigational Site
Avellino, Campania, 83100
GSK Investigational Site
Bari, Apulia, 70124
GSK Investigational Site
Bologna, Emilia-Romagna, 40138
GSK Investigational Site
Genoa, Liguria, 16132
GSK Investigational Site
Milan, Lombardy, 20122
GSK Investigational Site
Milan, Lombardy, 20132
GSK Investigational Site
Milan, Lombardy, 20162
GSK Investigational Site
Naples, Campania, 80123
GSK Investigational Site
Padova, Veneto, 35128
GSK Investigational Site
Palermo, Sicily, 90127
GSK Investigational Site
Rome, Lazio, 00133
GSK Investigational Site
Rome, Lazio, 00168
GSK Investigational Site
San Giovanni Rotondo (FG), Apulia, 71013
GSK Investigational Site
Turin, Piedmont, 10126
Spain14 sites
GSK Investigational Site
Barakaldo, 48903
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
L'Hospitalet de Llobregat, 08907
GSK Investigational Site
Madrid, 28007
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Málaga, 29010
GSK Investigational Site
Oviedo, 33006
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Valencia, 46009
GSK Investigational Site
Valencia, 46014
GSK Investigational Site
Valladolid, 47012
France10 sites
GSK Investigational Site
Clermont Ferrand Cédex 1, 63058
GSK Investigational Site
Lyon, 69288
GSK Investigational Site
Lyon, 69437
GSK Investigational Site
Marseille, 13385
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Nice, 06202
GSK Investigational Site
Paris, 75014
GSK Investigational Site
Paris, 75571
GSK Investigational Site
Paris, 75651
GSK Investigational Site
Villejuif, 94804
Argentina5 sites
GSK Investigational Site
Buenos Aires, 1264
GSK Investigational Site
Capital Fefderal, Buenos Aires
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACI
GSK Investigational Site
Derqui, Pilar, Buenos Aires, B1629AHJ
GSK Investigational Site
Rosario, Santa Fe Province, S2002KDR
Poland5 sites
GSK Investigational Site
Chorzów, 41-500
GSK Investigational Site
Lubin, 59-301
GSK Investigational Site
Słupsk, 76-200
GSK Investigational Site
Warsaw, 01-201
GSK Investigational Site
Wroclaw, 50-367
South Korea5 sites
GSK Investigational Site
Busan, 614-735
GSK Investigational Site
Incheon, 400-711
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 135-710
GSK Investigational Site
Seoul, 138-736
Taiwan5 sites
GSK Investigational Site
Douliu, 640
GSK Investigational Site
Kaohsiung City, 807
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 112
GSK Investigational Site
Taoyuan
Canada4 sites
GSK Investigational Site
Calgary, Alberta, T2N 4Z6
GSK Investigational Site
Montreal, Quebec, H2X 3J4
GSK Investigational Site
Ottawa, Ontario, K1H 8L6
GSK Investigational Site
Toronto, Ontario, M6H 3M1
Russia4 sites
GSK Investigational Site
Saint Petersburg, 194044
GSK Investigational Site
Samara, 443011
GSK Investigational Site
Smolensk, 214006
GSK Investigational Site
Yekaterinburg, 620102
Belgium3 sites
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Ghent, 9000
India3 sites
GSK Investigational Site
Jaipur, 302004
GSK Investigational Site
Mumbai, 400 016
GSK Investigational Site
Mumbai, 400020
Pakistan2 sites
GSK Investigational Site
Lahore, 54000
GSK Investigational Site
Lahore, 54600
About this study
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
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
- Being tested
- Eltrombopag, Placebo
- Keywords
- elective invasive procedure., platelet transfusion, chronic liver disease-related thrombocytopenia, platelets, thrombopoietin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, HIV Infections, Thrombocytopenia, Hepatitis C, Acquired Immunodeficiency Syndrome, Liver Diseases, Hepatitis B, Jacobs syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
75 mg, once daily, oral
PlaceboDrug
placebo, once daily, oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo, once daily, oral Receives: Drug: Placebo |
| Active | Active comparator | 75 mg, once daily, oral Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
A platelet transfusion was given if the platelet count was <50 giga (10^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was >80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure.
Measured: 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 (15)
Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures
The WHO Bleeding Scale was used to assess bleeding during the study. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small [1-2 millimeter] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality).
Measured: 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
Platelet transfusion use was documented at every visit throughout the study from screening until the 4-week (30-day) post-procedure follow-up visit or at the time of participant withdrawal from the study.
Measured: 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
Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).
Measured: 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
Procedure +7 = Days 23-26; +14 = Days 30-33; +21 = Days 37-40; +30 = Days 46-49. Early withdrawal can occur at any time. Maximum post-baseline refers to any time point listed above for which the maximum value was reached (therefore this time point is variable).
Measured: 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
An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect or an ocular event of clinical concern. Medical or scientific judgement is exercised in deciding whether reporting is appropriate in other situations.
Measured: 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
Measured: Screening to Procedure +30 day follow-up or early withdrawal
Number of Participants With the Indicated Event Relating to Vision
The progression of pre-existing cataracts was measured by the use of slit lamp examination. Decrease in visual acuity is defined as the loss of 3 or more lines of visual acuity in either eye (0.3 log minimal angle of resolution [logMAR], 15 letters on the standard Early Treatment Diabetic Retinopathy Study chart).
Measured: Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit)
Number of Participants With Renal Function Abnormality
Renal function abnormality was defined by threshold values for: serum creatinine: change from baseline of >=0.3 and <0.5 milligrams (mg)/deciliter (dL) (>=26.6 and <44.3 micromoles [umol]/L) or change from baseline of >=0.5 mg/dL (>=44.3 umol/L); microscopic urine analysis: cellular casts pathologic (as defined by local standards of microscopic urine analysis); urine protein/creatinine ratio (UP/CR): >0.5 mg/mg; Glomerular Filtration Rate (GFR) as determined by the Cockcroft-Gault formula and urine dipstick test.
Measured: Screening to Procedure +30 day follow-up or early withdrawal
Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results
A 12-lead ECG was obtained in duplicate at screening, baseline, Day 15, and withdrawal from the study. Participants rested supine for 5 minutes before the 12-lead ECG was recorded. A 30 second rhythm strip was obtained, and the ECG was calibrated, labelled, and initialled by the person performing the recording. A written, interpretive assessment detailing clinical significance was produced, dated, and signed off by the physician at the site.
Measured: Screening, Baseline, Day 15, and Withdrawal
Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau)
AUC(0-tau) is the area under a concentration versus time curve between dose interval following repeat dosing. It is a measure of systemic drug exposure.
Measured: Day 14
Pharmacokinetics (PK) of Eltrombopag, Cmax
Cmax is the steady state peak plasma concentration of a drug observed after its administration.
Measured: Day 14
Pharmacokinetics (PK) of Eltrombopag, t1/2
t1/2 is the half life of a drug based on its terminal phase. Half life is defined as the time necessary to halve the plasma concentration.
Measured: Day 14
Pharmacokinetics (PK) of Eltrombopag, CL/F
CL/F is the apparent plasma clearance, where CL is an estimate of the total body clearance, and F is the fraction of dose absorbed. Total clearance is the volume of blood cleared of the drug by the various elimination processes (metabolism and excretion) per unit time.
Measured: Day 14
Mean Number of Days Spent in the Hospital
The number of days spent in the hospital was analyzed as an indication of medical resource utilization throughout the study.
Measured: 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
The number of unscheduled events was analyzed as an indication of medical resource utilization throughout the study.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: GSK decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678587
- Sponsor's protocol ID
- TPL104054
- Acronym
- ELEVATE
- Status last verified
- Jan 2013
- First submitted
- 13 May 2008
- Last updated
- 12 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 Aug 23;367(8):716-24. doi: 10.1056/NEJMoa1110709.
PubMed 22913681
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00678587
- Acronym / sponsor ID
- ELEVATE / TPL104054
- Conditions
- Non-alcoholic Steatohepatitis, Chronic Liver Disease, HCV, NASH - Nonalcoholic Steatohepatitis, HIV Infection, Thrombocytopenia
- Keywords
- elective invasive procedure., platelet transfusion, chronic liver disease-related thrombocytopenia, platelets, thrombopoietin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: GSK decision
- Enrolment
- 292 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Posted 8 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboplacebo, once daily, oral |
| Active | Active comparator | Drug: Eltrombopag75 mg, once daily, oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eltrombopag75 mg, once daily, oral | Drug | Active |
| Placeboplacebo, once daily, oral | Drug | Placebo |
Primary outcome
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
Time frame: 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
A platelet transfusion was given if the platelet count was <50 giga (10^9) per liter (Gi/L) before the procedure. A platelet transfusion was not given if the platelet count was >80 Gi/L (based on a primary endpoint of success). For participants with platelet counts between 50 Gi/L and 80 Gi/L, platelet transfusions were administered at the discretion of the investigator and the physician performing the elective invasive procedure.
15 secondary outcomes
Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Screening to Procedure +30 day follow-up or early withdrawal
Number of Participants With the Indicated Event Relating to Vision
Time frame: Screening or Baseline and at End of Study (Procedure +30 day follow-up or withdrawal visit)
Number of Participants With Renal Function Abnormality
Time frame: Screening to Procedure +30 day follow-up or early withdrawal
Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results
Time frame: Screening, Baseline, Day 15, and Withdrawal
Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau)
Time frame: Day 14
Pharmacokinetics (PK) of Eltrombopag, Cmax
Time frame: Day 14
Pharmacokinetics (PK) of Eltrombopag, t1/2
Time frame: Day 14
Pharmacokinetics (PK) of Eltrombopag, CL/F
Time frame: Day 14
Mean Number of Days Spent in the Hospital
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22913681Afdhal 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.
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Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
RecruitingPhase 2
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
107 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eltrombopag in people with Non-alcoholic Steatohepatitis and Chronic Liver Disease, run by GlaxoSmithKline at 107 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 107 sites in United States, Italy, Spain, France, Argentina and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00678587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.