drugset / Trial / NCT00597909
Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).
Timeline
- Start
- 2007-12
- Primary completion
- 2008-09
- Completion
- 2008-09
Outcome
Outcome not reported
Stopped (Enrollment): “Study was terminated due to lack of enrollment and business decisions.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Phenylacetate and Sodium Benzoate | Unknown | 2.75 g | Intravenous |
| Subject | Sodium Phenylacetate and Sodium Benzoate | Unknown | 5.5 g | Intravenous |