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EXTEND (Eltrombopag Extended Dosing Study) (EXTEND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00351468
First received: July 10, 2006
Last updated: March 5, 2017
Last verified: March 2017
Results First Received: July 6, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Purpura, Thrombocytopaenic, Idiopathic
Intervention: Drug: eltrombopag olamine (SB-497115-GR)

  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
Subjects were previously enrolled in a study of eltrombopag: TRA100773A, TRA100773B, TRA102537/RAISE, or TRA108057/REPEAT. Eligibility of consenting subjects was assessed during the screening period of up to 28 days prior to Day 1 of treatment.

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
Eltrombopag Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.

Participant Flow:   Overall Study
    Eltrombopag
STARTED   302 
Subjects From TRA100773A   51 
Subjects From TRA100773B   61 
Subjects From TRA102537 Raise   146 
Subjects From TRA108057 Repeat   43 
Unknown - Not From Previous Trial   1 [1] 
COMPLETED   135 
NOT COMPLETED   167 
Adverse Event                42 
Withdrawal by Subject                39 
Various -follow up w clinical team                39 
Lack of Efficacy                32 
Non-compliance                8 
Lost to Follow-up                4 
Protocol Violation                3 
[1] Mistakenly enrolled (not in any of the 3 trials) On 50 mg/d eltrombopag for 18 days and withdrawn



  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.
No text entered.

Reporting Groups
  Description
Eltrombopag Open-label eltrombopag was supplied in 25, 50, 75 mg tablets. All subjects started at 50mg once daily and dose was increased or decreased based on platelet count (target range 50-200Gi/L). Alternate days and interruption of dosing was permitted to maintain target range of platelet count. Doses could range from 25 to 75mg. Subjects could remain on treatment up to 2 years.

Baseline Measures
   Eltrombopag 
Overall Participants Analyzed 
[Units: Participants]
 302 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.9  (15.61) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      201  66.6% 
Male      101  33.4% 
Concomitant ITP Medication at Baseline 
[Units: Participant]
 
Yes   101 
No   201 
Splenectomy Status at Baseline 
[Units: Participants]
 
Yes   115 
No   187 
Baseline Platelet Count 
[Units: Participants]
 
<30 Gi/L   211 
30 - 50 Gi/L   52 
> 50 Gi/L   39 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Summary of On-Therapy Adverse Events (Safety Population)   [ Time Frame: Start date was the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product up to week 364 ]

2.  Secondary:   Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication   [ Time Frame: Baseline up to 2 years ]

3.  Secondary:   Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication   [ Time Frame: Baseline up to Year 7/Week 364 ]

4.  Secondary:   Number of Subjects Who Responded to Eltrombopag in a Previous Study and Who Respond to Retreatment With a Rise in Platelet Count to Either ≥ 50,000/µL or ≥30,000/µL   [ Time Frame: Baseline up to 2 years ]

5.  Secondary:   Number of Participants With Reduction and/or Sparing of Concomitant ITP Therapies, While Maintaining a Platelet Count ≥ 50,000/mL.   [ Time Frame: Baseline up to 2 years ]

6.  Secondary:   Number of Subjects Who Required Rescue Therapy During Treatment With Eltrombopag.   [ Time Frame: Baseline up to 2 years ]

7.  Secondary:   Maximum ITP Bleeding Score at Any Time During the Study During All Stages.   [ Time Frame: Baseline up to 2 years ]

8.  Secondary:   Best Post-Baseline Change in SF-36v2 Questionnaire Score From Any Time Point Compared With Baseline   [ Time Frame: Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years ]

9.  Secondary:   Best Post-Baseline Change in the Short Form of the Motivation and Energy Scale (MEI-SF) From Any Time Point Compared With Baseline   [ Time Frame: Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years ]

10.  Secondary:   Best Post-Baseline Change in the FACIT-Fatigue 13 Item Subscale Score From Any Time Point Compared to Baseline   [ Time Frame: Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years ]

11.  Secondary:   Best Post-Baseline Change in the FACT-TH6 at Any Time Point Compared to Baseline   [ Time Frame: Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 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: Study Director
Organization: Novartis
phone: 862-778-8300


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00351468     History of Changes
Other Study ID Numbers: TRA105325
Study First Received: July 10, 2006
Results First Received: July 6, 2016
Last Updated: March 5, 2017