Evaluation of Repeat Administration of Purified Poloxamer 188

Mast Therapeutics, Inc.16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sickle Cell Disease

Interventions

MST-188DRUG

Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (9)

Rady Children's Hospital

San Diego, California, United States

Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Joe Dimaggio Children's Hospital

Hollywood, Florida, United States

Outcomes

Primary Outcomes

Safety as measured as the incidence of adverse events

Time frame: 30 days after administration of study drug

Secondary Outcomes

Rate of re-hospitalization for recurrence of VOC

Time frame: Within 14 days of the date of discharge

Occurrence of acute chest syndrome

Time frame: Within 120 hours of registration

Data from ClinicalTrials.gov

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