A Longitudinal 2-year Bone Marrow Study of Eltrombopag in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01098487
First received: March 25, 2010
Last updated: February 26, 2015
Last verified: February 2015
Results First Received: January 5, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Purpura, Thrombocytopaenic, Idiopathic
Intervention: Drug: Eltrombopag olamine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 167 participants were enrolled and received at least one dose of study medication. The 5 enrolled participants from center 082877 were excluded from the analysis due to the following: serious good clinical practice (GCP) findings related to informed consent, source documents and investigator study oversight.

Reporting Groups
  Description
Eltrombopag Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.

Participant Flow:   Overall Study
    Eltrombopag  
STARTED     162  
COMPLETED     118  
NOT COMPLETED     44  
Adverse Event                 22  
Lack of Efficacy                 11  
Withdrawal by Subject                 7  
Lost to Follow-up                 3  
Physician Decision                 1  



  Baseline Characteristics
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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.
All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877.

Reporting Groups
  Description
Eltrombopag Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.

Baseline Measures
    Eltrombopag  
Number of Participants  
[units: participants]
  162  
Age [1]
[units: Years]
Mean (Standard Deviation)
  43.1  (16.31)  
Gender  
[units: Participants]
 
Female     104  
Male     58  
Race/Ethnicity, Customized  
[units: Participants]
 
Asian - Central/South Asian Heritage     47  
Asian - East Asian Heritage     32  
Asian - South East Asian Heritage     1  
White - White/Caucasian/European Heritage     81  
Missing     1  
[1] All Treated Subjects (ATS) Population: all participants who received at least one dose of study medication excluding the 5 participants from Center 082877.



  Outcome Measures
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1.  Primary:   Number of Participants With Bone Marrow (BM) Fibers of MF Grade 0, 1, 2 and 3 on the European Consensus (EC) Scale at Baseline   [ Time Frame: Baseline ]

2.  Primary:   Number of Participants With a Positive or Negative Collagen Level at Baseline   [ Time Frame: Baseline ]

3.  Primary:   Number of Participants With Indicated Grade Change From Baseline in the EC Grading Scale at 1 Year   [ Time Frame: Baseline and 1 year ]

4.  Primary:   Number of Participants With Indicated Change From Baseline in the EC Grading Scale at 2 Years   [ Time Frame: Baseline and 2 years ]

5.  Primary:   Number of Participants With a Positive or Negative Collagen Level at 1 Year   [ Time Frame: 1 year ]

6.  Primary:   Number of Participants With a Positive or Negative Collagen Level at 2 Year   [ Time Frame: 2 years ]

7.  Secondary:   Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During the Study   [ Time Frame: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) ]

8.  Secondary:   Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During the Study   [ Time Frame: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) ]

9.  Secondary:   Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Started On-therapy + 1 Day, >1 to 30 Days Post Therapy and >30 Days Post Therapy   [ Time Frame: From Week 1 up to Week 104 and up to 6 months follow-up (4 weeks for most participants) (up to approximately 2.5 years) ]


  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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  More Information
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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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01098487     History of Changes
Other Study ID Numbers: 112940
Study First Received: March 25, 2010
Results First Received: January 5, 2015
Last Updated: February 26, 2015
Health Authority: Hong Kong: Department of Health
Korea: Korea Food & Drug Administration
United States: Food and Drug Administration