Evaluation of Repeat Administration of Purified Poloxamer 188

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02449616

Acronym

EPIC-E

Enrollment

Registered

2015-05-20

Start date

2015-06-30

Completion date

Unknown

Last updated

2016-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

Sickle cell, vaso-occlusive crisis

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.

Interventions

DRUGMST-188

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Safety as measured as the incidence of adverse events	30 days after administration of study drug

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026