Back to resultsAcetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.
Primary Purpose
Quality of Life, Daily Activity, Fatigue
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Acetyl-L-carnitine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Quality of Life focused on measuring Acetyl-L-carnitine, Interferons, Ribavirin, Hepatitis C, Fatigue
Eligibility Criteria
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.
Sites / Locations
- University of Catania, Cannizzaro Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Acetyl-L-carnitine
placebo
Arm Description
Acetyl-L-carnitine 2 gr tablets
Outcomes
Primary Outcome Measures
Work performances
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01909557
Brief Title
Acetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Daily Activity, Fatigue
Keywords
Acetyl-L-carnitine, Interferons, Ribavirin, Hepatitis C, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetyl-L-carnitine
Arm Type
Active Comparator
Arm Description
Acetyl-L-carnitine 2 gr tablets
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetyl-L-carnitine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Work performances
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Catania, Cannizzaro Hospital
City
Catania
ZIP/Postal Code
95125
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Acetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.
We'll reach out to this number within 24 hrs