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

University of Catania

Status and phase: Completed; Phase 4

Conditions: Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis; Fatigue in Workers With Chronic C Hepatitis; Fatigue

Treatments: Drug: Acetylcarnitine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01913964

10/1997

Details and patient eligibility

About

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.

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

Acetyl-L-carnitine

Experimental group

Description:

2 g daily for 12 months

Treatment:

Drug: Acetylcarnitine

placebo

Placebo Comparator group

Treatment:

Drug: Placebo