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

Fatigue Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913964
• Other study ID #: 10/1997
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2013
• Last updated: July 31, 2013
• Start date: October 1997
• Est. completion date: October 1997

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 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: 0
• Est. completion date: October 1997
• Est. primary completion date: October 1997
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Fatigue
• Fatigue in Workers With Chronic C Hepatitis
• Hepatitis
• Hepatitis A
• Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis

Intervention

Drug:
• Acetylcarnitine

• Placebo
(sugar pill)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work Productivity and Activity Impairment in workers with chronic hepatitis C	Work productivity loss, impairment in daily activities, presenteeism, absenteeism, will be assessed using the Work Productivity and Activity Impairment questionnaire.	12 months	No
Secondary	Fatigue in workers with chronic hepatitis C	Severity of fatigue, mental fatigue and physical fatigue.	12 months	No