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

Last updated: February 8, 2007
Sponsor: Aga Khan University
Overall Status: Completed

Phase

3

Condition

Hepatic Encephalopathy

Vomiting

Arginase Deficiency

Treatment

N/A

Clinical Study ID

NCT00433368
OA001
  • Ages 14-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cirrhosis, diagnosed on the basis of clinical findings, sonographic, and/or histologicbasis,

  • Patients >14 years, with HE grades 1 to 4 according to West Haven Criteria,

  • Hyperammonemia (fasting venous blood ammonia level >60 µmol/l), and

  • Patients with a single reversible precipitating factor of HE such as constipation,hypokalemia, urinary tract infection, respiratory tract infection, spontaneousbacterial peritonitis (SBP), dehydration, or none.

Exclusion

Exclusion Criteria:

  • hepatocellular carcinoma,

  • severe septicemia,

  • active gastrointestinal bleeding,

  • hepatorenal syndrome,

  • acute superimposed liver injury,

  • advanced cardiac or pulmonary disease and end stage renal failure,

  • patients with minimal HE

  • patients taking sedatives, antidepressants, or benzodiazepines and

  • patients with chronic HE on metronidazole or lactulose prior to admission.

Study Design

Total Participants: 108
Study Start date:
October 01, 2003
Estimated Completion Date:
September 30, 2004

Study 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.

Connect with a study center

  • Aga Khan University Hospital

    Karachi, Sind 74800
    Pakistan

    Site Not Available

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