NCT00597909 - Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions

Hepatic Encephalopathy

Interventions

DRUG

sodium phenylacetate and sodium benzoate injection 10% / 10%

5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)

DRUG

sodium phenylacetate and sodium benzoate injection 10% / 10%

2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)

DRUG

placebo solution (10% dextrose)

Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)

Trial Locations (3)

79761

Permian Research Foundation, Odessa

92354

Loma Linda University Medical Center, Loma Linda

93721

UCSF-Fresno University, Fresno