Evaluation of Repeat Administration of Purified Poloxamer... | NCT02449616

Studies
Evaluation of Repeat Administration of Purified Poloxamer 188

NCT02449616

Sponsor

Mast Therapeutics, Inc.

Status

Completed

Last Update Posted

Oct 28, 2016Estimated

Enrollment

16Actual

Phase

Phase 3

Conditions

Sickle Cell Disease

Interventions

MST-188

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Sep 2016Actual

Completion Date

Not provided

First Submitted Date

May 18, 2015

First Submission Date that Met QC Criteria

May 18, 2015

First Posted Date

May 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2016

Last Update Posted Date

Oct 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Drug	Experimental	MST-188	Drug: MST-188

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MST-188	Drug	Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.	Study Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edwin L Parsley, D. O.	Mast Therapeutics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rady Children's Hospital		San Diego	California		United States
Children's Hospital of Southwest Florida

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell
D000098644	Vaso-Occlusive Crises

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided