MedDataX Logo

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

NCT ID: NCT01913964

Last Updated: 2013-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

1997-10-31

Study Completion Date

1997-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acetyl-L-carnitine

2 g daily for 12 months

Group Type EXPERIMENTAL

Acetylcarnitine

Intervention Type DRUG

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

(sugar pill)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acetylcarnitine

Intervention Type DRUG

Placebo

(sugar pill)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Catania

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mariano Malaguarnera

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10/1997

Identifier Type: -

Identifier Source: org_study_id