NCT00470314

Brief Summary

The purpose of the study is to determine whether L-Ornithine L-Aspartate infusion improves the survival of patients with acute liver failure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
Last Updated

January 7, 2008

Status Verified

April 1, 2007

First QC Date

May 4, 2007

Last Update Submit

January 4, 2008

Conditions

Acute Liver Failure

Keywords

Acute liver failureOrnithine AspartateAmmoniaEncephalopathy

Outcome Measures

Primary Outcomes (1)

  • Improvement in survival.

    Within 30 days of disease onset

Secondary Outcomes (6)

  • Reduction in ammonia levels during and at the end of 72 hour LOLA infusion.

    72 hours

  • Improvement of encephalopathy by one or more grades.

    72 hours

  • Reduction of consciousness recovery time (CRT) among survivors.

    Within 30 days of disease onset

  • Prolongation of time to death among non-survivors.

    Within 30 days of disease onset

  • Prevention / reduction of cerebral edema.

    72 hours

  • +1 more secondary outcomes

Interventions

L-Ornithine L-AspartateDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acute liver failure, as defined by the development of encephalopathy within 4 weeks of onset of symptoms in the absence of preexisting liver disease.

You may not qualify if:

  • Presence of \> 3 adverse prognostic factors (Age \> 40 years, clinical evidence of cerebral edema, bilirubin \>15mg/dL, and prothrombin time prolonged by \> 25 seconds) at the initial patient evaluation.
  • Suspicion of underlying cirrhosis.
  • Previous treatment with LOLA or other ammonia lowering treatments before admission.
  • Malarial hepatopathy, enteric hepatitis, alcoholic hepatitis, or ischemic hepatitis.
  • Active alcohol use of \>40 gm/week at the onset of illness.
  • Renal insufficiency at admission, as defined by a urine output of \<500 mL/d and /or creatinine level of \> 3mg/dL.
  • Inability to randomize within 24 hours of admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences

Delhi, India

Location

Related Publications (6)

  • Bhatia V, Singh R, Acharya SK. Predictive value of arterial ammonia for complications and outcome in acute liver failure. Gut. 2006 Jan;55(1):98-104. doi: 10.1136/gut.2004.061754. Epub 2005 Jul 15.

    PMID: 16024550BACKGROUND

  • Clemmesen JO, Larsen FS, Kondrup J, Hansen BA, Ott P. Cerebral herniation in patients with acute liver failure is correlated with arterial ammonia concentration. Hepatology. 1999 Mar;29(3):648-53. doi: 10.1002/hep.510290309.

    PMID: 10051463BACKGROUND

  • 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 Nov;19(3):424-30. doi: 10.1016/s0168-8278(05)80553-7.

    PMID: 8151104BACKGROUND

  • Kircheis G, Nilius R, Held C, Berndt H, Buchner M, Gortelmeyer R, Hendricks R, Kruger B, Kuklinski B, Meister H, Otto HJ, Rink C, Rosch W, Stauch S. 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 Jun;25(6):1351-60. doi: 10.1002/hep.510250609.

    PMID: 9185752BACKGROUND

  • Rose C, Michalak A, Rao KV, Quack G, Kircheis G, Butterworth RF. L-ornithine-L-aspartate lowers plasma and cerebrospinal fluid ammonia and prevents brain edema in rats with acute liver failure. Hepatology. 1999 Sep;30(3):636-40. doi: 10.1002/hep.510300311.

    PMID: 10462368BACKGROUND

  • Acharya SK, Bhatia V, Sreenivas V, Khanal S, Panda SK. Efficacy of L-ornithine L-aspartate in acute liver failure: a double-blind, randomized, placebo-controlled study. Gastroenterology. 2009 Jun;136(7):2159-68. doi: 10.1053/j.gastro.2009.02.050.

    PMID: 19505424DERIVED

Related Links

MeSH Terms

Conditions

Liver Failure, AcuteBrain Diseases

Interventions

ornithylaspartate

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Subrat Kr Acharya, M.D., D.M.

    All India Institute of Medical Sciences

    STUDY DIRECTOR

  • Vikram Bhatia, M.D., D.M.

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Amit Singhal, M.D.

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2007

First Posted

May 7, 2007

Study Start

January 1, 2005

Study Completion

May 1, 2007

Last Updated

January 7, 2008

Record last verified: 2007-04

Locations

IN(1)