NCT01913964

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 1997

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1997

Completed
15.8 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

Same day

First QC Date

July 26, 2013

Last Update Submit

July 31, 2013

Conditions

Work Productivity and Activity Impairment in Workers With Chronic C HepatitisFatigue in Workers With Chronic C HepatitisFatigue

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Fatigue in workers with chronic hepatitis C

    12 months

Study Arms (2)

Acetyl-L-carnitine

EXPERIMENTAL

2 g daily for 12 months

Drug: Acetylcarnitine

placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AcetylcarnitineDRUG
Acetyl-L-carnitine
PlaceboDRUG

(sugar pill)

placebo

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fatigue

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarnitineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 26, 2013

First Posted

August 1, 2013

Study Start

October 1, 1997

Primary Completion

October 1, 1997

Study Completion

October 1, 1997

Last Updated

August 1, 2013

Record last verified: 2013-07