Evaluation of Repeat Administration of Purified Poloxamer 188
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 4 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| Contact: | Edwin L. Parsley, D.O. |
| Email: | eparsley@mastthera.com |
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
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.
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.
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
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