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

U

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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