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

Phase 4CompletedNCT01913964

University of Catania

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis Fatigue in Workers With Chronic C Hepatitis Fatigue

Interventions

AcetylcarnitineDRUG

PlaceboDRUG

(sugar pill)

Eligibility

Sex: ALLMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Work Productivity and Activity Impairment in workers with chronic hepatitis C

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

Time frame: 12 months

Secondary Outcomes

Fatigue in workers with chronic hepatitis C

Severity of fatigue, mental fatigue and physical fatigue.

Time frame: 12 months

Data from ClinicalTrials.gov

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