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CompletedNCT00433368Updated Feb 9, 2007

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

A Phase 3 interventional study of L-Ornithine L-Aspartate in Hepatic Encephalopathy, sponsored by Aga Khan University. Completed at 1 site in Pakistan. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-02-09.

Sponsored by Aga Khan University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
14 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Hepatic Encephalopathy

Keywords

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

Hepatic Encephalopathy

218 studies on the registry are indexed under Hepatic Encephalopathy; 48 are open to participants now.

This study's enrollment of 108 is above the median of 60 across 148 interventional studies indexed under Hepatic Encephalopathy.

Browse Hepatic Encephalopathy studies →

Lead sponsor

Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
108 participants

Interventions

  • DrugL-Ornithine L-Aspartate
06

What researchers measure

Primary outcomes

  1. Improvement in HE grade.

  2. deterioration in HE grade.

Secondary outcomes

  1. Length of hospital stay

  2. fasting ammonia level and

  3. mortality rate

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Study locations

1 site
  • Aga Khan University Hospital
    Karachi, Sind 74800, Pakistan
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References and documents

Publications

  • [1] ] STAEDT U, LEWELING H, GLADISCH R, KORTSIK C, HAGMULLER E, HOLM E. Effects of ornithine aspartate on plasma ammonia and plasma amino acids in patients with cirrhosis. A double-blind, randomized study using a four-fold crossover design. J Hepatol 1993;19(3): 424-430. [2] KIRCHEIS G, NILIUS R, HELD C, BERNDT H, BUCHNER M, GÖRTELMEYER R, et al. Therapeutic efficacy of L-ornithine-L-aspartate infusions in patients with cirrhosis and hepatic encephalopathy: results of a placebo-controlled, double-blind study. Hepatology 1997;25(6):1351-1360. [3] FEHÉR J, LÁNG I, GÓGL A, VARGA L, TOMPOS G, PRÓNAI L. Effect of ornithine-aspartate infusion on elevated serum ammonia concentration in cirrhotic patients - results of a randomized, placebo-controlled double-blind multicentre trial. Med Sci Monit 1997; 3(5):669-673. [4] KIRCHEIS G, WETTSTEIN M, VOM DAHL S, HÄUSSINGER D. Clinical efficacy of L-ornithine-L-aspartate in the management of hepatic encephalopathy. Met Brain Dis 2002;17(4): 453-462. [5] REES CJ, OPPONG K, AL MARDINI H, HUDSON M, RECORD CO. Effect of L- ornithine-L-aspartate on patients with and without TIPS undergoing glutamine challenge: a double blind, placebo controlled trial. Gut 2000; 47(4): 571-574.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00433368
Lead sponsor
Aga Khan University
First posted
Feb 9, 2007
Start date
Oct 2003
Completion
Sep 2004
Last update
Feb 9, 2007

Study contacts

Wasim Jafri, MD; FRCP
study chair · Chairman Department of Medicine, Aga Khan University Hospital
Shahab Abid, MD
principal investigator · Associate Professor, Department of Medicine, Aga Khan University
View the source record on ClinicalTrials.gov ↗

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