Conditions: Immune Thrombocytopenia
Keywords: Splenectomy Low Platelet Count Thrombopoiesis Thrombocytopaenia Idiopathic Thrombocytopenic Purpura Immune Thrombocytopenia (ITP) Thrombotic Thrombocytopenic Purpura (ITP) Hematologic Disease Auto-immune Thrombocytopenic Purpura S-888711 Blood Platelet Disorders Relapsed Persistent or Chronic ITP ITP
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 19
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts. If a subject's platelet count remained \< 50,000/μL, the dose could have been increased by 0.25 mg up to a maximum dose of 2.0 mg.

Interventions: intervention 1: Lusutrombopag
Intervention descriptions: intervention 1: tablet

Protocol document: