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Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia Prior to Elective Surgical or Diagnostic Procedures

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ClinicalTrials.gov Identifier: NCT00914927
Recruitment Status : Completed
First Posted : June 5, 2009
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Thrombocytopenia Related to Chronic Liver Disease
Interventions: Drug: Avatrombopag
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort A: 20 mg Avatrombopag, 1G Formulation Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
Cohort A: 40 mg Avatrombopag, 1G Formulation Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
Cohort A: 80 mg Avatrombopag, 1G Formulation Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
Cohort A: Placebo, 1G Formulation Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
Cohort B: 0 mg Avatrombopag, 2G Formulation Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
Cohort B: 20 mg Avatrombopag, 2G Formulation Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
Cohort B: Placebo, 2G Formulation Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.

Participant Flow:   Overall Study
    Cohort A: 20 mg Avatrombopag, 1G Formulation   Cohort A: 40 mg Avatrombopag, 1G Formulation   Cohort A: 80 mg Avatrombopag, 1G Formulation   Cohort A: Placebo, 1G Formulation   Cohort B: 0 mg Avatrombopag, 2G Formulation   Cohort B: 20 mg Avatrombopag, 2G Formulation   Cohort B: Placebo, 2G Formulation
STARTED   18   16   17   16   21   21   21 
COMPLETED   16   14   17   14   19   21   21 
NOT COMPLETED   2   2   0   2   2   0   0 
Adverse Event                0                0                0                0                1                0                0 
Withdrawal by Subject                0                1                0                1                0                0                0 
Lost to Follow-up                0                0                0                1                0                0                0 
Administrative/Other                2                1                0                0                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to Treat (ITT) population included all participants who were randomized into the study, received study medication, and had a post-treatment assessment.

Reporting Groups
  Description
Cohort A: 20 mg Avatrombopag, 1G Formulation Participants received a 100 mg loading dose of the first generation (1G) formulation avatrombopag on Day 1, followed by 20 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
Cohort A: 40 mg Avatrombopag, 1G Formulation Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 40 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
Cohort A: 80 mg Avatrombopag, 1G Formulation Participants received a 100 mg loading dose of the 1G formulation avatrombopag on Day 1, followed by 80 mg of the 1G formulation avatrombopag once daily on Days 2 to 7.
Cohort A: Placebo, 1G Formulation Participants received the 1G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
Cohort B: 10 mg Avatrombopag, 2G Formulation Participants received an 80 mg loading dose of the second generation (2G) formulation avatrombopag on Day 1, followed by 10 mg 2G formulation avatrombopag once daily on Days 2 to 7.
Cohort B: 20 mg Avatrombopag, 2G Formulation Participants received an 80 mg loading dose of the 2G formulation avatrombopag on Day 1, followed by 20 mg 2G formulation avatrombopag once daily on Days 2 to 4 followed by 2G avatrombopag-matched placebo once daily on Days 5 to 7.
Cohort B: Placebo, 2G Formulation Participants received the 2G formulation avatrombopag-matched placebo loading dose on Day 1, then once daily on Days 2 to 7.
Total Total of all reporting groups

Baseline Measures
   Cohort A: 20 mg Avatrombopag, 1G Formulation   Cohort A: 40 mg Avatrombopag, 1G Formulation   Cohort A: 80 mg Avatrombopag, 1G Formulation   Cohort A: Placebo, 1G Formulation   Cohort B: 10 mg Avatrombopag, 2G Formulation   Cohort B: 20 mg Avatrombopag, 2G Formulation   Cohort B: Placebo, 2G Formulation   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   16   17   16   21   21   21   130 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.3  (7.16)   52.8  (7.78)   55.2  (5.96)   54.2  (6.87)   53.9  (5.48)   56.8  (6.46)   55.6  (6.52)   54.8  (6.56) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Female      4  22.2%      3  18.8%      6  35.3%      5  31.3%      10  47.6%      7  33.3%      7  33.3%      42  32.3% 
Male      14  77.8%      13  81.3%      11  64.7%      11  68.8%      11  52.4%      14  66.7%      14  66.7%      88  67.7% 


  Outcome Measures

1.  Primary:   Percentage of Participants Experiencing Response   [ Time Frame: Day 8 (Visit 5, EOT) ]

2.  Secondary:   Change in Platelet Count on Day 8 (Visit 5 and/or End of Treatment) From Baseline   [ Time Frame: Day 8 (Visit 5, EOT) ]

3.  Secondary:   Percentage of Participants Experiencing Dose-response by Visit   [ Time Frame: Day 4 (Visit 3), Day 6 ( Visit 4), Day 8 (Visit 5, EOT), 3 Day Post Last Dose (Visit 6), and 7 Day Post Last Dose (Visit 7) ]

4.  Secondary:   Percentage of Participants Who Achieved a Platelet Count Greater Than 75,000/mm^3 on Day 4   [ Time Frame: Day 4 (Visit 3) ]

5.  Secondary:   Percentage of Participants Who Achieved a Platelet Count Greater Than 100,000/mm^3 on Days 4 and 8   [ Time Frame: Day 4 (Visit 3) and Day 8 (Visit 5, EOT) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Eisai Medical Services
Organization: Eisai Inc.
phone: 1-888-422-4743



Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00914927     History of Changes
Other Study ID Numbers: E5501-G000-202
First Submitted: June 4, 2009
First Posted: June 5, 2009
Results First Submitted: December 5, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018