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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01913964

Enrollment

Unknown

Registered

2013-08-01

Start date

1997-10-31

Completion date

1997-10-31

Last updated

2013-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGAcetylcarnitine

DRUGPlacebo

(sugar pill)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

45 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026