drugset / Trial / NCT00742482
Efficacy and Safety of 3 Doses of HL10 Given at Fixed Time Intervals Compared to Standard Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to evaluate the efficacy and safety of three doses of HL 10 given at fixed time intervals compared to standard therapy
Timeline
- Start
- 2003-01
- Primary completion
- 2005-01
- Completion
- 2005-06
Outcome
Missed primary endpoint
Stopped: “A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.”
paper The 28-day death rate in the usual care group was 24.5% compared with 28.8% in the HL 10 group. PMID 19713451 ↗
paper The estimated odds ratio for death at Day 28 in the usual care group versus the HL 10 group was 0.75 (95% CI, 0.48-1.18; P = 0.22). PMID 19713451 ↗
Publications
- Lu Q, Zhang M, Girardi C, Bouhemad B, Kesecioglu J, Rouby JJ. Computed tomography assessment of exogenous surfactant-induced lung reaeration in patients with acute lung injury. Crit Care. 2010;14(4):R135. doi: 10.1186/cc9186. Epub 2010 Jul 15.
- Kesecioglu J, Beale R, Stewart TE, Findlay GP, Rouby JJ, Holzapfel L, Bruins P, Steenken EJ, Jeppesen OK, Lachmann B. Exogenous natural surfactant for treatment of acute lung injury and the acute respiratory distress syndrome. Am J Respir Crit Care Med. 2009 Nov 15;180(10):989-94. doi: 10.1164/rccm.200812-1955OC. Epub 2009 Aug 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HL 10 | Protein / enzyme biologic | 200 mg/kg | Other |