NCT00433368

Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy

Efficacy of a Three Days' Infusion of L-Ornithine-L-Aspartate as an Adjuvant Therapy in Cirrhotic Patients With Overt Hepatic Encephalopathy: A Placebo Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (planned)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether L-Ornithine L-Aspartate is effective for the improvement of Overt Hepatic Encephalopathy.

Detailed description

There is no effective treatment available for hepatic encephalopathy at the moment; therefore we aimed to check the efficacy and safety of L-ornithine L-aspartate(LOLA). It provides critical substrates for ureagenesis and glutamine synthesis, the two primary mechanisms by which the body rids itself of excess ammonia. Ornithine is a specific activator of ornithine carbamyl transferase and carbamylphosphate synthetase, and, in addition, is a substrate for ureagenesis. These reactions are carried out mainly in the periportal portion of the hepatic lobules. Aspartate and ornithine, after conversion to alfa-ketoglutarate, are substrates for glutamine synthesis, which is performed exclusively by a small population of perivenous hepatocytes, the so-called perivenous scavenger cells. The ammonia lowering effect resulting from the stimulation of these two basic mechanisms of ammonia detoxification has been studied in animals and was confirmed in humans in clinical trials.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	L-Ornithine L-Aspartate

Timeline

• Start date: 2003-10-01
• Completion: 2004-09-01
• First posted: 2007-02-09
• Last updated: 2007-02-09

Locations

1 site across 1 country: Pakistan