Acetyl-L-Carnitine Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin

To assess the effects of Acetyl-L-Carnitine administration on work productivity, daily activity, and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.

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Key information

Conditions

Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis Fatigue Fatigue in Workers With Chronic C Hepatitis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

workers who were 18 years of age or older
Workers who were infected by HCV and had a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE)
Cirrhotic workers with a Child-Pugh score less than 7

Exclusion criteria

workers who had other liver diseases
cancer
severe jaundice
pulmonary and renal chronic diseases,
prostatic diseases
autoimmune diseases
diabetes mellitus
decompensated cirrhosis
pregnancy
cardiopathy
hemoglobinopathies
hemocromatosis
major depression
severe psychiatric pathological conditions

Treatment and study plan

Acetylcarnitine

Drug

Placebo

Drug

(sugar pill)

Primary outcomes

Work Productivity and Activity Impairment in workers with chronic hepatitis C

Time frame: 12 months

Work productivity loss, impairment in daily activities, presenteeism, absenteeism, will be assessed using the Work Productivity and Activity Impairment questionnaire.

Secondary outcomes

Fatigue in workers with chronic hepatitis C

Time frame: 12 months

Severity of fatigue, mental fatigue and physical fatigue.

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Important dates

Study start: 1997
Primary completion: 1997
Study completion: 1997
First posted: Aug 1, 2013
Registry last updated: Aug 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed