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


Phase 3
20 Years
N/A
Open (Enrolling)
Both
Essential Thrombocythaemia

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Trial Information

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


Inclusion Criteria:



- Subjects must have completed Study SPD422 308

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of long-term use of SPD422

Outcome Description:

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.

Outcome Time Frame:

3, 6, 9 and 12 months

Safety Issue:

Yes

Principal Investigator

Kanakura, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Osaka University Hospital

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

SPD422-309

NCT ID:

NCT01467661

Start Date:

November 2011

Completion Date:

May 2015

Related Keywords:

  • Essential Thrombocythaemia
  • Thrombocythemia, Essential
  • Thrombocytosis

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