Evaluation of Repeat Administration of Purified Poloxamer 188

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mast Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Completed participation in study MST-188-01 (EPIC study)

• Subject age 4 through 65 years

• Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia

• Subject requires hospitalization

Exclusion Criteria:

• Subject has acute chest syndrome

• Subject's laboratory results indicate inadequate organ function

• Subject is pregnant or nursing an infant

• Subject had a painful crisis requiring hospitalization within the preceding 14 days

• Subject has been transfused within the past 14 days

• Subject has complications related to SCD