drugset / Trial / NCT02113735
Safety and Efficacy Study of Acthar in Subjects With ARDS
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is being performed to evaluate the potential efficacy and safety of Acthar as a treatment for moderate-severe Acute Respiratory Distress Syndrome (ARDS). Approximately 210 subjects will be randomized to 1 of 6 possible treatment groups in a 3:2:3:2:3:2 ratio. Study medication (SM) will be administered via subcutaneous (SC) injection for 4 weeks using a blinded gradually tapering regimen, and subjects will be followed for 60 days post-randomization.
Timeline
- Start
- 2014-08
- Primary completion
- 2016-08
- Completion
- 2016-08
Outcome
Outcome not reported
Stopped: “A company decision was made not to proceed with the study.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | repository corticotropin injection | Unknown | 16 iu | Subcutaneous |
| Subject | repository corticotropin injection | Unknown | 32 iu | Subcutaneous |
| Subject | repository corticotropin injection | Unknown | 64 iu | Subcutaneous |