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An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)

Immune Thrombocytopenia Clinical Trial

Official title:
An Open-label Safety Study of S-888711 in Adult Subjects With Relapsed Persistent or Chronic Immune Thrombocytopenia With or Without Prior Splenectomy

Clinical Trial Summary

The primary objective of this study was to assess the long-term safety of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy.

Clinical Trial Description

This was an open-label, long-term safety study of lusutrombopag in the treatment of adults with relapsed persistent or chronic ITP with or without prior splenectomy. Patients who participate in this study must have completed the Phase 2 study 0913M0621 (NCT01054443), a double-blind, placebo controlled, parallel group study that evaluated the efficacy and safety lusutrombopag during which they either completed treatment or discontinued treatment due to a platelet count > 400,000/μL. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01129024
Study type Interventional
Source Shionogi Inc.
Contact
Status Terminated
Phase Phase 2
Start date April 29, 2010
Completion date June 30, 2011
View Details
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