Evaluation of Purified Poloxamer 188 in Subjects with Sickle Cell Disease Experiencing a Vaso-occlusive Crisis

Phase 1

• Conditions: Sickle Cell Disease with Vaso-Occlusive Crisis; MedDRA version: 18.0Level: LLTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2013-002986-21-BE
• Lead Sponsor: Mast Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-09
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

1. Age 4 through 65 years
2. Subject has a confirmed diagnosis of HbSS, HbSC, HbSß+thal, or HbSß0thal
3. Subject is experiencing acute pain typical of vaso-occlusive crisis requiring treatment with parenteral analgesia
4. Subject requires hospitalization
Are the trial subjects under 18? yes
Number of subjects for this age range: 232
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 155
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

1. Subject has acute chest syndrome
2. Subject's laboratory results indicate inadequate organ function
3. Subject is pregnant or nursing an infant
4. Subject had a painful crisis requiring hospitalization within the preceding 14 days or has experienced > 5 hospitalizations for VOC in the prior 6 months
5. Subject has been transfused within the past 14 days
6. Subject is hospitalized for a condition other than VOC
7. Subject has complications related to SCD

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified