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

Quality of Life Clinical Trial

Official title:

Effect of Supplementation of Antioxidant Substances and Probiotics in HCV Correlated Liver Disease Treated With Interferon and Ribavirin. Studies on Biochemical and Virological Response and on Quality of Life.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909557
• Other study ID #: Unict10/1997
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2013
• Last updated: July 25, 2013
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: July 2013
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Daily Activity
• Fatigue
• Quality of Life

Intervention

Drug:
• Acetyl-L-carnitine

• placebo

Locations

Country	Name	City	State
Italy	University of Catania, Cannizzaro Hospital	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work performances		12 months	Yes