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Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01467661
First received: October 31, 2011
Last updated: June 22, 2016
Last verified: June 2016
Results First Received: May 2, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Essential Thrombocythemia (ET)
Intervention: Drug: SPD422 (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
The study was conducted in 15 centers in the Japan between 27 October 2010 and 01 May 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall 53 participants were enrolled in study SPD422-308 (NCT01214915), 42 of them completed the study. Of these 42 participants, 41 entered in to the current extension study SPD422-309 (NCT01467661) with 33 of 41 participants entered the post marketing trial and 32 participants completed the study (after marketing approval was granted).

Reporting Groups
  Description
SPD422 (Anagrelide Hydrochloride) Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.

Participant Flow:   Overall Study
    SPD422 (Anagrelide Hydrochloride)
STARTED   53 [1] 
Completed SPD422-308 (NCT01214915)   42 
Started SPD422-309 (NCT01467661)   41 
Started Post Marketing Trial   33 
COMPLETED   32 [2] 
NOT COMPLETED   21 
Adverse Event                16 
Withdrawal by Subject                1 
Lack of Efficacy                3 
Not enrolled to SPD422-309 (NCT01467661)                1 
[1] Started Study SPD422-308 (NCT01214915)
[2] Completed study SPD422-309 (NCT01467661)



  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.
Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).

Reporting Groups
  Description
SPD422 (Anagrelide Hydrochloride) Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.

Baseline Measures
   SPD422 (Anagrelide Hydrochloride) 
Overall Participants Analyzed 
[Units: Participants]
 53 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.6  (13.10) 
Gender 
[Units: Participants]
 
Female   30 
Male   23 


  Outcome Measures
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1.  Primary:   Change From Baseline in Platelet Count at Final Assessment   [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ]

2.  Primary:   Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment   [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ]

3.  Primary:   Percentage of Participants Who Achieved Platelet Count Less Than (<) 600   [ Time Frame: Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product) ]

4.  Primary:   Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial   [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ]

5.  Primary:   Percentage of Participants Who Achieved Shift From Baseline in Platelet Count   [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ]

6.  Primary:   Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial   [ Time Frame: Baseline and final assessment (within 5 days of the last dose of investigational product) ]

7.  Primary:   Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)   [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ]

8.  Primary:   Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial   [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ]

9.  Primary:   Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result   [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ]

10.  Primary:   Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial   [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ]

11.  Primary:   Percentage of Participants With TEAEs and TESAEs Related to Vital Signs   [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ]

12.  Primary:   Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial   [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ]

13.  Primary:   Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities   [ Time Frame: From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product ]


  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 Physician
Organization: Shire
phone: 1 866-842-5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01467661     History of Changes
Other Study ID Numbers: SPD422-309
Study First Received: October 31, 2011
Results First Received: May 2, 2016
Last Updated: June 22, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency