Clinical trial NCT02449616: Evaluation of Repeat Administration of Purified Poloxamer 188
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sickle Cell Disease
Keywords: Sickle cell
vaso-occlusive crisis
Lead sponsor: Mast Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-20
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety as measured as the incidence of adverse events
timeFrame: 30 days after administration of study drug
Secondary outcomes:
measure: Rate of re-hospitalization for recurrence of VOC
timeFrame: Within 14 days of the date of discharge
measure: Occurrence of acute chest syndrome
timeFrame: Within 120 hours of registration
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Fort Myers
country: United States
facility: Children's Hospital of Southwest Florida
state: Florida
city: Hollywood
country: United States
facility: Joe Dimaggio Children's Hospital
state: Florida
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Children's Hospital
state: Iowa
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Children's Hospital
state: Louisiana
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: T. C. Thompson Children's Hospital
state: Tennessee
Study officials:
affiliation: Mast Therapeutics, Inc.
name: Edwin L Parsley, D. O.
role: STUDY_DIRECTOR
References: