Clinical Trial Details

Trial ID: L0364
Source ID: NCT00678587
Associated Drug: Eltrombopag
Title: Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures
Acronym: ELEVATE
Status: Terminated
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT00678587/results
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
Interventions: Drug: Eltrombopag|Drug: Placebo
Outcome Measures: 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|Number of Participants With a World Health Organization (WHO) Bleeding Score >=2 During and up to 7 Days Following Elective Invasive Procedures|Number of Participants With the Indicated Number of Platelet Transfusions Administered|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|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|Number of Participants Experiencing an Adverse Event (AEs) and Serious Adverse Event (SAEs) Within the Indicated Category|Number of Participants With a Serious Adverse Event That Occurred in Greater Than One Participant|Number of Participants With the Indicated Event Relating to Vision|Number of Participants With Renal Function Abnormality|Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results|Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau)|Pharmacokinetics (PK) of Eltrombopag, Cmax|Pharmacokinetics (PK) of Eltrombopag, t1/2|Pharmacokinetics (PK) of Eltrombopag, CL/F|Mean Number of Days Spent in the Hospital|Mean Number of Unscheduled Office Visits, Unscheduled Laboratory Tests, and Unscheduled Procedures
Sponsor/Collaborators: GlaxoSmithKline
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 3
Enrollment: 292
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: June 2008
Completion Date: October 2009
Results First Posted: November 7, 2010
Last Update Posted: October 12, 2018
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, 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, Argentina|GSK Investigational Site, Ciudad Autonoma de Buenos Aires, Argentina|GSK Investigational Site, Brussels, Belgium|GSK Investigational Site, Edegem, Belgium|GSK Investigational Site, Gent, 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 C??dex 1, France|GSK Investigational Site, Lyon Cedex 02, 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 Cedex 12, France|GSK Investigational Site, Paris Cedex 13, 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, Avellino, Campania, Italy|GSK Investigational Site, Napoli, Campania, Italy|GSK Investigational Site, Bologna, Emilia-Romagna, Italy|GSK Investigational Site, Roma, Lazio, Italy|GSK Investigational Site, Roma, Lazio, Italy|GSK Investigational Site, Genova, Liguria, Italy|GSK Investigational Site, Milano, Lombardia, Italy|GSK Investigational Site, Milano, Lombardia, Italy|GSK Investigational Site, Milano, Lombardia, Italy|GSK Investigational Site, Torino, Piemonte, Italy|GSK Investigational Site, Bari, Puglia, Italy|GSK Investigational Site, San Giovanni Rotondo (FG), Puglia, Italy|GSK Investigational Site, Palermo, Sicilia, Italy|GSK Investigational Site, Padova, Veneto, Italy|GSK Investigational Site, Busan, Korea, Republic of|GSK Investigational Site, Incheon, Korea, Republic of|GSK Investigational Site, Seoul, Korea, Republic of|GSK Investigational Site, Seoul, Korea, Republic of|GSK Investigational Site, Seoul, Korea, Republic of|GSK Investigational Site, Lahore, Pakistan|GSK Investigational Site, Lahore, Pakistan|GSK Investigational Site, Chorzow, Poland|GSK Investigational Site, Lubin, Poland|GSK Investigational Site, Slupsk, Poland|GSK Investigational Site, Warszawa, Poland|GSK Investigational Site, Wroclaw, Poland|GSK Investigational Site, Ekaterinburg, Russian Federation|GSK Investigational Site, Saint-Petersburg, Russian Federation|GSK Investigational Site, Samara, Russian Federation|GSK Investigational Site, Smolensk, Russian Federation|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, Hospitalet de Llobregat, Spain|GSK Investigational Site, Madrid, Spain|GSK Investigational Site, Madrid, Spain|GSK Investigational Site, M??laga, Spain|GSK Investigational Site, Oviedo, Spain|GSK Investigational Site, Sevilla, Spain|GSK Investigational Site, Valencia, Spain|GSK Investigational Site, Valencia, Spain|GSK Investigational Site, Valladolid, Spain|GSK Investigational Site, Douliou, Taiwan|GSK Investigational Site, Kaohsiung, Taiwan|GSK Investigational Site, Taipei, Taiwan|GSK Investigational Site, Taipei, Taiwan|GSK Investigational Site, Taoyuan, Taiwan
URL: https://ClinicalTrials.gov/show/NCT00678587

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D400 Eltrombopag Chemical drug DB06210 -- -- Under clinical trials Details
D010 Amoxicillin Chemical drug DB01060 -- -- Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details
D223 Metabolic Cofactor Supplementation Supplement -- -- -- Under clinical trials Details
D248 Obeticholic Acid Chemical drug DB05990 NR1H4 activator; NR1H4 agonist; FXR agonist Enhance lipid metabolism Approval rejected Details
D328 Serine Chemical drug DB00133 SRR Improve insulin resistance Under clinical trials Details