Evaluation of Repeat Administration of Purified Poloxamer 188

Sickle Cell Disease Clinical Trial

— EPIC-E  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449616
• Other study ID #: MST-188-04
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2015
• Last updated: October 26, 2016
• Start date: June 2015

Study information

• Verified date: October 2016
• Source: Mast Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• MST-188
Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.

Locations

Country	Name	City	State
United States	Our Lady of the Lake Children's Hospital	Baton Rouge	Louisiana
United States	Medical University of South Carolina	Charleston	South Carolina
United States	T. C. Thompson Children's Hospital	Chattanooga	Tennessee
United States	Ann and Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Children's Hospital of Southwest Florida	Fort Myers	Florida
United States	Joe Dimaggio Children's Hospital	Hollywood	Florida
United States	University of Iowa Children's Hospital	Iowa City	Iowa
United States	Rutgers University	New Brunswick	New Jersey
United States	Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Mast Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured as the incidence of adverse events		30 days after administration of study drug	Yes
Secondary	Rate of re-hospitalization for recurrence of VOC		Within 14 days of the date of discharge	No
Secondary	Occurrence of acute chest syndrome		Within 120 hours of registration	No