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Acthar Gel in ARDS
NCT02113735Phase 2
Key facts
- Status
- Withdrawn
- Start
- Aug 2014
- Primary completion
- Aug 2016
- Sponsor
- Mallinckrodt Pharmaceuticals
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- acute respiratory distress syndrome (ARDS)
01
Overview
Phase 2, randomised, double-blind trial of repository corticotropin injection in acute respiratory distress syndrome (ARDS) (6 arms), sponsored by Mallinckrodt Pharmaceuticals. Primary endpoint: Number of ventilator-free days at Day 28. Planned start Aug 2014; status: withdrawn.
02
Design
6 arms- Study design
- RandomizedDouble-blind
Acthar Gel 64 U QD
Acthar Gel 64 U (0.8 mL) daily
Placebo QD
Placebo 0.8 mL daily
Acthar Gel 32 U BID
Acthar Gel 32 U (0.4 mL) twice daily
Placebo BID
Placebo 0.4 mL twice daily
Acthar Gel 16 U BID
Acthar Gel 16 U (0.2 mL) twice daily
Placebo BID
Placebo 0.2 mL twice daily
03
Who it enrols
Adult patients with moderate-severe ARDS (PaO2/FiO2 <= 200 mmHg) enrolled within 24 hours to 10 days of criteria onset. Excludes patients with severe comorbidities, active untreated infections, or contraindications to Acthar.
04
Endpoints
Primary
Number of ventilator-free days
Secondary
Mortality
Number of ICU-free days
Number of hospital-free days
Number of extra-pulmonary organ failure-free days
Change in PaO2/FiO2 ratio
Change in oxygenation index (OI)
Change in Systemic Organ Failure Assessment Score
Number of treatment-emergent serious adverse events
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