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

Phase 4

Completed

• Conditions: Fatigue; Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis; Fatigue in Workers With Chronic C Hepatitis
• Interventions: Drug: Placebo; Drug: Acetylcarnitine

• Registration Number: NCT01913964
• Lead Sponsor: University of Catania

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-10
• Primary Completion: 1997-10
• Study Completion: 1997-10
• Status Verified: 2013-07
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-07-31
• Last Update Submitted: 2013-07-31
• Study First Posted: 2013-08-01
• Last Update Posted: 2013-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
Acetyl-L-carnitine	Acetylcarnitine	2 g daily for 12 months

Primary Outcome Measures

Name	Time	Method
Work Productivity and Activity Impairment in workers with chronic hepatitis C	12 months	Work productivity loss, impairment in daily activities, presenteeism, absenteeism, will be assessed using the Work Productivity and Activity Impairment questionnaire.

Secondary Outcome Measures

Name	Time	Method
Fatigue in workers with chronic hepatitis C	12 months	Severity of fatigue, mental fatigue and physical fatigue.