Acetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.

Phase 3

Completed

• Conditions: Quality of Life; Daily Activity; Fatigue
• Interventions: Drug: placebo; Drug: Acetyl-L-carnitine

• Registration Number: NCT01909557
• Lead Sponsor: University of Catania

Brief Summary

To assess the effects of Acetyl-L-Carnitine, probiotics and antioxidant nutritional substances 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: 2010-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-07
• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-25
• Last Update Submitted: 2013-07-25
• Study First Posted: 2013-07-26
• Last Update Posted: 2013-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Eligible patients are workers who are 18 years of age or older, infected by HCV with a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE). HCV infected populations must have elevated serum alanine transaminase levels and findings on liver biopsy consistent with chronic infection. Cirrhotic patients have to have a Child-Pugh score less than 7 to be eligible.

Exclusion Criteria

• Ineligible patients are those who had other liver diseases, as well as those who are affected by cancer, severe jaundice, pulmonary and renal chronic diseases, prostatic diseases, autoimmune diseases and diabetes mellitus. Excessive use of alcohol (>20 g/die) or hepato-toxic drugs. Other causes of exclusion include decompensated cirrhosis, pregnancy, and contraindications for Peg-IFN-a or RBV therapy such as cardiopathy, hemoglobinopathies, hemocromatosis, major depression or other severe psychiatric pathological conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
Acetyl-L-carnitine	Acetyl-L-carnitine	Acetyl-L-carnitine 2 gr tablets

Primary Outcome Measures

Name	Time	Method
Work performances	12 months

Trial Locations

Locations (1)

University of Catania, Cannizzaro Hospital; 🇮🇹 Catania, Italy