Evaluation of Repeat Administration of Purified Poloxamer 188

Phase 3

Completed

• Conditions: Sickle Cell Disease
• Interventions: Drug: MST-188

• Registration Number: NCT02449616
• Lead Sponsor: Mast Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-20
• Study Start: 2015-06
• Primary Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Drug	MST-188	MST-188

Primary Outcome Measures

Name	Time	Method
Safety as measured as the incidence of adverse events	30 days after administration of study drug

Secondary Outcome Measures

Name	Time	Method
Rate of re-hospitalization for recurrence of VOC	Within 14 days of the date of discharge
Occurrence of acute chest syndrome	Within 120 hours of registration

Trial Locations

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

Ann and Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Iowa Children's Hospital; 🇺🇸 Iowa City, Iowa, United States

Our Lady of the Lake Children's Hospital; 🇺🇸 Baton Rouge, Louisiana, United States

Rutgers University; 🇺🇸 New Brunswick, New Jersey, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

T. C. Thompson Children's Hospital; 🇺🇸 Chattanooga, Tennessee, United States