NCT02449616

Evaluation of Repeat Administration of Purified Poloxamer 188

Evaluation of Repeat Administration of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC-E): An Open-Label Safety Extension Trial Assessing Repeat Administration of MST-188 (Purified Poloxamer 188) Injection in Subjects With Sickle Cell Disease Experiencing Vaso Occlusive Crisis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Mast Therapeutics, Inc. · Industry
• Sex: All
• Age: 4 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of repeat administration of MST-188 during vaso-occlusive crisis of sickle cell disease. Additionally, this study will evaluate the development of acute chest syndrome during VOC and re-hospitalization for recurrence of VOC.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	MST-188	Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-09-01
• First posted: 2015-05-20
• Last updated: 2016-10-28

Locations

9 sites across 1 country: United States