Status:
COMPLETED
Acetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.
Lead Sponsor:
University of Catania
Conditions:
Quality of Life
Daily Activity
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 tre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01909557
Start Date
January 1 2010
End Date
December 1 2011
Last Update
July 26 2013
Active Locations (1)
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1
University of Catania, Cannizzaro Hospital
Catania, Italy, 95125