Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)

Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC): A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial 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

NCT01737814

Acronym

EPIC

Enrollment

388

Registered

2012-11-30

Start date

2013-05-31

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, Vaso-occlusive Crisis

Keywords

sickle cell disease, vaso-occlusive crisis

Brief summary

The purpose of this study is to evaluate whether MST-188 can reduce the duration of vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a recurrence of VOC. Additionally, this study will compare the development of acute chest syndrome during VOC in subjects who receive MST-188 to those who do not receive MST-188.

Interventions

DRUGSaline

DRUGMST-188

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

4 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age 4 through 65 years * Subject has a confirmed diagnosis of HbSS, HbSC, HbSβ+thal, or HbSβ0thal * Subject is experiencing acute pain typical of vaso-occlusive crisis requiring treatment with parenteral 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 or has experienced \> 5 hospitalizations for VOC in the prior 6 months * Subject has been transfused within the past 14 days * Subject is hospitalized for a condition other than VOC * Subject has complications related to SCD

Design outcomes

Primary

Measure	Time frame
Reduction of the duration of vaso occlusive crisis (VOC) in subjects with sickle cell disease.	Study participants will be followed for the duration of hospital stay, an expected average of 4 days

Secondary

Measure	Time frame
Re-hospitalization rate for VOC	Hospital discharge to 14 days post-discharge
Occurence of acute chest syndrome	Randomization to 120 hours after randomization

Countries

Belgium, Brazil, Dominican Republic, Jamaica, Jordan, Lebanon, Oman, Panama, Spain, Turkey (Türkiye), United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026