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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Multi-centre, Open-label, Extension Study to Investigate the Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia

Brief Summary: The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome:

• 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) ]
  Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).
• 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) ]
  Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).
• 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) ]
  Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter at each visit were reported.
• Percentage of Participants Who Achieved
  
  

  Original Primary Outcome: Safety of long-term use of SPD422 [ Time Frame: 3, 6, 9 and 12 months ]

  Safety will be determined by the changes from study baseline in clinical laboratory evaluations, vital signs, and electrocardiograms (ECGs) recorded as an AE if clinically relevant.
  
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome: Platelet count [ Time Frame: 3, 6, 9 and 12 months ]
  
  Information By: Shire
  

  Dates:
  Date Received: October 31, 2011
  Date Started: November 2011
  Date Completion:
  Last Updated: June 22, 2016
  Last Verified: June 2016