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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00433368
Other study ID # OA001
Secondary ID
Status Completed
Phase Phase 3
First received February 8, 2007
Last updated February 8, 2007
Start date October 2003
Est. completion date September 2004

Study information

Verified date February 2007
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority Pakistan: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date September 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 14 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
L-Ornithine L-Aspartate


Locations

Country Name City State
Pakistan Aga Khan University Hospital Karachi Sind

Sponsors (1)

Lead Sponsor Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

[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

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in HE grade.
Primary deterioration in HE grade.
Secondary Length of hospital stay
Secondary fasting ammonia level and
Secondary mortality rate
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