drugset / Trial / NCT00789685
Safety, Tolerability and Preliminary Efficacy of FP-1201 in ALI and ARDS. Phase I/II
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study was to assess the safety, tolerability and preliminary efficacy of FP-1201 (Interferon Beta) in patients with Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).
Timeline
- Start
- 2009-02
- Primary completion
- 2011-09
- Completion
- 2011-09
Outcome
Met primary endpoint
paper By day 28, 3 (8%) of 37 patients in the treatment cohort and 19 (32%) of 59 patients in the control cohort had died PMID 24503265 ↗
paper treatment with FP-1201 was associated with an 81% reduction in odds of 28-day mortality (odds ratio 0·19 [95% CI 0·03-0·72]; p=0·01). PMID 24503265 ↗
Publications
- Background Kiss J, Yegutkin GG, Koskinen K, Savunen T, Jalkanen S, Salmi M. IFN-beta protects from vascular leakage via up-regulation of CD73. Eur J Immunol. 2007 Dec;37(12):3334-8. doi: 10.1002/eji.200737793.
- Results Bellingan G, Maksimow M, Howell DC, Stotz M, Beale R, Beatty M, Walsh T, Binning A, Davidson A, Kuper M, Shah S, Cooper J, Waris M, Yegutkin GG, Jalkanen J, Salmi M, Piippo I, Jalkanen M, Montgomery H, Jalkanen S. The effect of intravenous interferon-beta-1a (FP-1201) on lung CD73 expression and on acute respiratory distress syndrome mortality: an open-label study. Lancet Respir Med. 2014 Feb;2(2):98-107. doi: 10.1016/S2213-2600(13)70259-5. Epub 2013 Dec 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Interferon-beta | Protein / enzyme biologic | 0.12 unknown | Intravenous |
| Subject | Interferon-beta | Protein / enzyme biologic | 1.2 unknown | Intravenous |
| Subject | Interferon-beta | Protein / enzyme biologic | 2.7 unknown | Intravenous |
| Subject | Interferon-beta | Protein / enzyme biologic | 6 unknown | Intravenous |