NCT01214915

Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia

A Phase 3, Open-label, Single-arm Study Evaluating the Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia Who Are Intolerant or Refractory to Current Cytoreductive Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's previously treatment has either not been effective or has caused unacceptable adverse reactions. The study will aim to show that platelet counts can be safely reduced in treated patients to below 600 x 10\^9/L after a minimum of three months treatment. To demonstrate an positive effect platelet levels will need to remain below 600 x 10\^9/L for at least 4 weeks.

Conditions

• Essential Thrombocythemia (ET)

Interventions

Type	Name	Description
DRUG	Anagrelide Hydrochloride	Subjects will be started at 1.0 mg per day and titrated as necessary.

Timeline

• Start date: 2010-10-27
• Primary completion: 2012-10-24
• Completion: 2012-10-24
• First posted: 2010-10-05
• Last updated: 2021-06-09
• Results posted: 2013-09-25

Locations

19 sites across 1 country: Japan