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Acetyl-L-Carnitine In Severe Hepatic Encephalopathy

NCT ID: NCT01223768

Last Updated: 2010-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2005-12-31

Brief Summary

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To assess the clinical efficacy of ALC in the treatment of severe hepatic encephalopathy (grade 3 of the West Haven grading scale), we performed a randomised, double blind placebo-controlled study administering ALC to cirrhotic patients, evaluating the effects on ammonia levels and performance in cognitive functions.

Detailed Description

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Conditions

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Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)

Study Groups

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Acetyl-L-carnitine

Group Type EXPERIMENTAL

Acetyl-l-Carnitine

Intervention Type DRUG

2g per day

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

twice per day

Interventions

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Acetyl-l-Carnitine

2g per day

Intervention Type DRUG

placebo

twice per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with severe hepatic encephalopathy (grade 3 of the West Haven grading scale) with hepatic cirrhosis

Exclusion Criteria

* Patients with a history of recent alcohol abuse, patients using psychotropic drugs (e.g., antipsychotics, interferon, benzodiazepines, anti-epileptics, sedatives and antidepressants)
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Locations

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Cannizzaro Hospital

Catania, , Italy

Site Status

Countries

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Italy

Other Identifiers

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8-12-00 C

Identifier Type: -

Identifier Source: org_study_id