Skip to content

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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00433368
Enrollment
108
Registered
2007-02-09
Start date
2003-10-31
Completion date
2004-09-30
Last updated
2007-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Keywords

L-ornithine-L-aspartate,, porto-systemic encephalopathy,, hepatic encephalopathy,, liver cirrhosis,, mental state

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-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.

Interventions

Sponsors

Aga Khan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Cirrhosis, diagnosed on the basis of clinical findings, sonographic, and/or histologic basis, * 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, spontaneous bacterial peritonitis (SBP), dehydration, or none.

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.

Design outcomes

Primary

MeasureTime frame
Improvement in HE grade.
deterioration in HE grade.

Secondary

MeasureTime frame
Length of hospital stay
fasting ammonia level and
mortality rate

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026