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Trial record 3 of 225 for:    "essential thrombocythemia"

French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia (FOX)

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ClinicalTrials.gov Identifier: NCT01192347
Recruitment Status : Completed
First Posted : September 1, 2010
Results First Posted : September 25, 2013
Last Update Posted : March 14, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Essential Thrombocythemia

  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
177 subjects were enrolled, but 2 never received Anagrelide Hydrochloride (Xagrid) and were excluded from the trial (n = 175).

Reporting Groups
  Description
Anagrelide Hydrochloride The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.

Participant Flow:   Overall Study
    Anagrelide Hydrochloride
STARTED   175 
COMPLETED   163 
NOT COMPLETED   12 
Death                3 
Lost to Follow-up                3 
Withdrawal by Subject                1 
Adverse Event                1 
Suspected serious adverse drug reaction                1 
Patient seen in different hospital                1 
Patient not visiting hospital regularly                1 
Patient did not show up for visits                1 



  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.
Safety Set was used for Baseline measures. Safety Set comprised all patients who had taken at least 1 dose of Anagrelide Hydrochloride and had at least 1 post-baseline safety assessment. Two patients did not receive Anagrelide Hydrochloride, therefore n = 175 for the Safety Set.

Reporting Groups
  Description
Anagrelide Hydrochloride The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.

Baseline Measures
   Anagrelide Hydrochloride 
Overall Participants Analyzed 
[Units: Participants]
 175 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.0  (15.4) 
Age, Customized 
[Units: Participants]
 
<=60 years   42 
>60 years   133 
Gender 
[Units: Participants]
 
Female   108 
Male   67 
Region of Enrollment [1] 
[Units: Participants]
 
France   177 
[1] All enrolled subjects


  Outcome Measures

1.  Primary:   Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation   [ Time Frame: 6 months ]

2.  Primary:   Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation   [ Time Frame: 6 months ]

3.  Primary:   Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: No Withdrawal of Previous Cytoreductive Therapy   [ Time Frame: 6 months ]

4.  Primary:   Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)   [ Time Frame: 6 months ]

5.  Primary:   Percentage of Subjects With Continuation of Anagrelide Hydrochloride at 6 Months: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)   [ Time Frame: 6 months ]

6.  Primary:   Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation   [ Time Frame: 6 months ]

7.  Primary:   Percentage of Subjects Achieving Platelet Target Response: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation   [ Time Frame: 6 months ]

8.  Primary:   Percentage of Subjects Achieving Platelet Target Response: No Withdrawal of Previous Cytoreductive Therapy   [ Time Frame: 6 months ]

9.  Primary:   Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)   [ Time Frame: 6 months ]

10.  Primary:   Percentage of Subjects Achieving Platelet Target Response: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)   [ Time Frame: 6 months ]

11.  Secondary:   Percentage of Subjects With Anagrelide Hydrochloride Starting Doses   [ Time Frame: 6 months ]

12.  Secondary:   Number of Subjects With Anagrelide Hydrochloride Titration Modifcations- First Modification Only   [ Time Frame: 6 months ]

13.  Secondary:   Summary of Adverse Drug Reactions (ADR): Withdrawal of Previous Cytoreductive Therapy Before Anagrelide Hydrochloride Initiation   [ Time Frame: 6 months ]

14.  Secondary:   Summary of Adverse Drug Reactions: Withdrawal of Previous Cytoreductive Therapy After Anagrelide Hydrochloride Initiation   [ Time Frame: 6 months ]

15.  Secondary:   Summary of Adverse Drug Reactions: No Withdrawal of Previous Cytoreductive Therapy   [ Time Frame: 6 months ]

16.  Secondary:   Summary of Adverse Drug Reactions: When the Dosing Was Consistent With the Summary of Product Characteristics (SmPC)   [ Time Frame: 6 months ]

17.  Secondary:   Summary of Adverse Drug Reactions: When the Dosing Was Inconsistent With the Summary of Product Characteristics (SmPC)   [ Time Frame: 6 months ]

18.  Secondary:   Maximum Daily Dose of Anagrelide Hydrochloride   [ Time Frame: 6 months ]


  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: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335


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

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01192347     History of Changes
Other Study ID Numbers: SPD422-702
First Submitted: August 26, 2010
First Posted: September 1, 2010
Results First Submitted: July 24, 2013
Results First Posted: September 25, 2013
Last Update Posted: March 14, 2014