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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Acetylcarnitine
Placebo
Sponsored by
University of Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Acetyl-L-carnitine

    placebo

    Arm Description

    2 g daily for 12 months

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Fatigue in workers with chronic hepatitis C
    Severity of fatigue, mental fatigue and physical fatigue.

    Full Information

    First Posted
    July 26, 2013
    Last Updated
    July 31, 2013
    Sponsor
    University of Catania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01913964
    Brief Title
    Acetyl-L-Carnitine Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1997 (undefined)
    Primary Completion Date
    October 1997 (Actual)
    Study Completion Date
    October 1997 (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 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
    Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis, Fatigue in Workers With Chronic C Hepatitis, Fatigue

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    Acetyl-L-carnitine
    Arm Type
    Experimental
    Arm Description
    2 g daily for 12 months
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Acetylcarnitine
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    (sugar pill)
    Primary Outcome Measure Information:
    Title
    Work Productivity and Activity Impairment in workers with chronic hepatitis C
    Description
    Work productivity loss, impairment in daily activities, presenteeism, absenteeism, will be assessed using the Work Productivity and Activity Impairment questionnaire.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Fatigue in workers with chronic hepatitis C
    Description
    Severity of fatigue, mental fatigue and physical fatigue.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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