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

July 31, 2013 updated by: Mariano Malaguarnera, University of Catania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Drug: Placebo
(sugar pill)
EXPERIMENTAL: Acetyl-L-carnitine
2 g daily for 12 months
Drug: Acetylcarnitine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work Productivity and Activity Impairment in workers with chronic hepatitis C
Time Frame: 12 months
Work productivity loss, impairment in daily activities, presenteeism, absenteeism, will be assessed using the Work Productivity and Activity Impairment questionnaire.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue in workers with chronic hepatitis C
Time Frame: 12 months
Severity of fatigue, mental fatigue and physical fatigue.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Primary Completion (ACTUAL)

October 1, 1997

Study Completion (ACTUAL)

October 1, 1997

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (ESTIMATE)

August 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2013

Last Update Submitted That Met QC Criteria

July 31, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/1997

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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