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Exploratory Multi-centre Trial In Patients With ET Treated With XAGRID® (EMIX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01352585
First received: May 10, 2011
Last updated: June 27, 2014
Last verified: June 2014
History of Changes
Results First Received: June 27, 2014  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Essential Thrombocythaemia
Intervention: Drug: Anagrelide hydrochloride

  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
No text entered.

Reporting Groups
  Description
Anagrelide Hydrochloride Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician

Participant Flow:   Overall Study
    Anagrelide Hydrochloride
STARTED   47 
COMPLETED   36 
NOT COMPLETED   11 
Adverse Event                3 
Lost to Follow-up                1 
Not specified                7 



  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
Anagrelide Hydrochloride Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician

Baseline Measures
   Anagrelide Hydrochloride 
Overall Participants Analyzed 
[Units: Participants]
 		 47 
Age 
[Units: Years]
Mean (Standard Deviation) 		 58.0  (14.87) 
Age 
[Units: Participants]
 		 
<=18 years   0 
Between 18 and 65 years   31 
>=65 years   16 
Gender 
[Units: Participants]
 		 
Female   28 
Male   19 
Region of Enrollment 
[Units: Participants]
 		 
Italy   47 


  Outcome Measures
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1.  Primary:   Number of Patients With Platelet Count ≤600x10^9/L After 12 Months   [ Time Frame: 1 year ]
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2.  Secondary:   Number of Patients With Platelet Count ≤400x10^9/L After 12 Months   [ Time Frame: 1 year ]
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3.  Secondary:   Platelet Count   [ Time Frame: 1 year ]
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4.  Secondary:   Red Blood Cell (RBC) Count   [ Time Frame: 1 year ]
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5.  Secondary:   White Blood Cell (WBC) Count   [ Time Frame: 1 year ]
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6.  Secondary:   Differential WBC Count   [ Time Frame: 1 year ]
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7.  Secondary:   Hemoglobin Concentration   [ Time Frame: 1 year ]
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8.  Secondary:   Hematocrit Level   [ Time Frame: 1 year ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  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 Physician
Organization: Shire Development LLC
phone: +1 866 842 5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01352585     History of Changes
Other Study ID Numbers: SPD422-703
Study First Received: May 10, 2011
Results First Received: June 27, 2014
Last Updated: June 27, 2014