Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433368
Status:
COMPLETED
Last Update Posted:
2007-02-09
First Post:
2007-02-08
Brief Title:
Efficacy of L-Ornithine-L-Aspartate in Cirrhotics With Hepatic Encephalopathy
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
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
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-aspartateLOLA 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None