Work Productivity and Activity Impairment in Workers With Chronic C HepatitisPhase 4NCT01913964
Acetyl-L-Carnitine Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin
A Phase 4 study testing Acetylcarnitine in people with Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis and Fatigue in Workers With Chronic C Hepatitis, run by University of Catania.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis, Fatigue in Workers With Chronic C Hepatitis, Fatigue
- What is being tested?
- Acetylcarnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 1997to Oct 1997
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- workers who had other liver diseases
- cancer
- severe jaundice
- pulmonary and renal chronic diseases,
- prostatic diseases
- autoimmune diseases
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- diabetes mellitus
- decompensated cirrhosis
- pregnancy
- cardiopathy
- hemoglobinopathies
- hemocromatosis
- major depression
- severe psychiatric pathological conditions
About this study
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.
- Conditions
- Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis, Fatigue in Workers With Chronic C Hepatitis, Fatigue
- Being tested
- Acetylcarnitine, Placebo
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcarnitineDrug
PlaceboDrug
(sugar pill)
| Study group | Role | What they receive |
|---|---|---|
| Acetyl-L-carnitine | Experimental | 2 g daily for 12 months Receives: Drug: Acetylcarnitine |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Fatigue in workers with chronic hepatitis C
Severity of fatigue, mental fatigue and physical fatigue.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startOct 1997
- Primary completionOct 1997
- Study completionOct 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work Productivity and Activity Impairment in Workers With Chronic C HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariano Malaguarnera, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913964
- Sponsor's protocol ID
- 10/1997
- Status last verified
- Jul 2013
- First submitted
- 26 Jul 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetyl-L-Carnitine Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin
- ClinicalTrials.gov ID
- NCT01913964
- Acronym / sponsor ID
- 10/1997
- Conditions
- Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis, Fatigue in Workers With Chronic C Hepatitis, Fatigue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- Oct 1997
- Primary completion
- Oct 1997 (actual)
- Study completion
- Oct 1997 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetyl-L-carnitine | Experimental | Drug: Acetylcarnitine2 g daily for 12 months |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- workers who had other liver diseases
- cancer
- severe jaundice
- pulmonary and renal chronic diseases,
- prostatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylcarnitine | Drug | Acetyl-L-carnitine |
| Placebo(sugar pill) | Drug | placebo |
Primary outcome
Work Productivity and Activity Impairment in workers with chronic hepatitis C
Time frame: 12 months
Work productivity loss, impairment in daily activities, presenteeism, absenteeism, will be assessed using the Work Productivity and Activity Impairment questionnaire.
1 secondary outcome
Fatigue in workers with chronic hepatitis C
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetylcarnitine in people with Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis and Fatigue in Workers With Chronic C Hepatitis, run by University of Catania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Productivity and Activity Impairment in workers with chronic hepatitis C (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2013.