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Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures (ELEVATE)

This study has been terminated.
(GSK decision)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00678587
First received: May 13, 2008
Last updated: February 7, 2013
Last verified: January 2013
Results First Received: October 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Non-alcoholic Steatohepatitis
Chronic Liver Disease
HCV
NASH.
HIV Infection
Thrombocytopenia
Hepatitis C Virus
HBV
Human Immunodeficiency Virus
Liver Diseases
Hepatitis B Virus
Interventions: Drug: Eltrombopag
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Matching placebo
Eltrombopag 75 mg Eltrombopag 75 mg administered orally once daily

Participant Flow:   Overall Study
    Placebo     Eltrombopag 75 mg  
STARTED     147     145  
COMPLETED     127     127  
NOT COMPLETED     20     18  
Adverse Event                 3                 3  
Lack of Efficacy                 1                 0  
Protocol Violation                 2                 1  
Study Closed/Terminated                 1                 0  
Lost to Follow-up                 3                 5  
Investigator Discretion                 2                 6  
Withdrew Consent                 8                 3  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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) ]

9.  Secondary:   Number of Participants With Renal Function Abnormality   [ Time Frame: Screening to Procedure +30 day follow-up or early withdrawal ]

10.  Secondary:   Number of Participants With a Clinically Significant Change in Electrocardiogram (ECG) Results   [ Time Frame: Screening, Baseline, Day 15, and Withdrawal ]

11.  Secondary:   Pharmacokinetics (PK) of Eltrombopag, Steady State AUC(0-tau)   [ Time Frame: Day 14 ]

12.  Secondary:   Pharmacokinetics (PK) of Eltrombopag, Cmax   [ Time Frame: Day 14 ]

13.  Secondary:   Pharmacokinetics (PK) of Eltrombopag, t1/2   [ Time Frame: Day 14 ]

14.  Secondary:   Pharmacokinetics (PK) of Eltrombopag, CL/F   [ Time Frame: Day 14 ]

15.  Secondary:   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 ]

16.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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