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Completed

NCT Number: NCT02449616

Evaluation of Repeat Administration of Purified Poloxamer 188

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Vaso-Occlusive Crises

Age range

4 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rady Children's Hospital, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MST-188

Drug

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

Other names: vepoloxamer

Primary outcomes

  1. Safety as measured as the incidence of adverse events

    Time frame: 30 days after administration of study drug

Secondary outcomes

  1. Rate of re-hospitalization for recurrence of VOC

    Time frame: Within 14 days of the date of discharge

  2. Occurrence of acute chest syndrome

    Time frame: Within 120 hours of registration

Sponsors and collaborators

Lead sponsor

Mast Therapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: EPIC-E

Important dates

Study start
2015
Primary completion
2016
First posted
May 20, 2015
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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