Evaluation of Repeat Administration of Purified Poloxamer 188 (EPIC-E)

Mast Therapeutics

Status and phase: Completed; Phase 3

Conditions: Sickle Cell Disease

Treatments: Drug: MST-188

Study type: Interventional

Funder types: Industry

Identifiers

NCT02449616

MST-188-04

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 4 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Study Drug

Experimental group

Description:

MST-188

Treatment:

Drug: MST-188