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

NCT00433368 | Completed Phase 3

• 1 other identifier: OA001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic Encephalopathy

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Improvement in HE grade.

• deterioration in HE grade.

Secondary Outcomes (3)

• Length of hospital stay

• fasting ammonia level and

• mortality rate

Interventions

L-Ornithine L-Aspartate DRUG

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Related 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;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.

  RESULT

MeSH Terms

Conditions

Hepatic Encephalopathy; Liver Cirrhosis

Interventions

ornithylaspartate

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wasim Jafri, MD; FRCP

  Chairman Department of Medicine, Aga Khan University Hospital

  STUDY CHAIR

• Shahab Abid, MD

  Associate Professor, Department of Medicine, Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: February 9, 2007
• Study Start: October 1, 2003
• Study Completion: September 1, 2004
• Last Updated: February 9, 2007

Record last verified: 2007-02

Locations

PA (1)