NCT01909557

Brief Summary

To assess the effects of Acetyl-L-Carnitine, probiotics and antioxidant nutritional substances administration on work productivity, daily activity, and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for phase_3 quality-of-life

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3 quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
Last Updated

July 26, 2013

Status Verified

July 1, 2013

Enrollment Period

1.9 years

First QC Date

July 24, 2013

Last Update Submit

July 25, 2013

Conditions

Quality of LifeDaily ActivityFatigue

Keywords

Acetyl-L-carnitineInterferonsRibavirinHepatitis CFatigue

Outcome Measures

Primary Outcomes (1)

  • Work performances

    12 months

Study Arms (2)

Acetyl-L-carnitine

ACTIVE COMPARATOR

Acetyl-L-carnitine 2 gr tablets

Drug: Acetyl-L-carnitine

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

Acetyl-L-carnitineDRUG
Acetyl-L-carnitine
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients are workers who are 18 years of age or older, infected by HCV with a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE). HCV infected populations must have elevated serum alanine transaminase levels and findings on liver biopsy consistent with chronic infection. Cirrhotic patients have to have a Child-Pugh score less than 7 to be eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Catania, Cannizzaro Hospital

Catania, 95125, Italy

Location

MeSH Terms

Conditions

FatigueHepatitis C

Interventions

Acetylcarnitine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CarnitineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
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 24, 2013

First Posted

July 26, 2013

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 26, 2013

Record last verified: 2013-07

Locations

IT(1)