Viral Hepatitis CBIOEPANCT03566966
Autoantibodies and Direct-acting Antivirals
An observational study of Viral Hepatitis C and Therapy Adverse Effect, run by University of Bari at 1 site in Italy.
Trial summary
The investigators assessed non-organ-specific antibodies before and 24 weeks after the end of therapy with direct-acting antivirals, in order to better clarify the clinical relevance of these antibodies in terms of treatment response and prognostic value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Hepatitis C, Therapy Adverse Effect
- What is being tested?
- Non-organ-specific Ab positive and Non-organ-specific Ab negative
- How many people
- 191 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2015to 31 Mar 2017
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Caucasian patients affected by chronic hepatitis C virus infection who were consecutively admitted as outpatients to the Gastroenterology Unit, Policlinic Hospital, Bari, Italy, from July 2015-August 2016 to receive a treatment with second generation direct-acting antivirals.
Who may be able to join
- HCV positive patients Presence of advanced liver fibrosis Eligibility to the treatment with direct-acting antiviral therapy.
Who cannot join
- History of autoimmune hepatitis and/or cholangitis Evidence of active hepatocellular carcinoma Human immunodeficiency virus coinfection Hepatitis B virus coinfection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Relevance of Serum Non-organ-specific Antibodies in Hepatitis C Virus Patients Receiving Direct-acting Antiviral Therapy
The investigators assessed non-organ-specific antibodies before and 24 weeks after the end of therapy with direct-acting antivirals, in order to better clarify the clinical relevance of these antibodies in terms of treatment response and prognostic value.
To achieve this goal patients with hepatitis C virus related advanced liver disease, with detectable circulating autoantibodies on at least two determinations before treatment, were enrolled.
Read the detailed description
About 40-70% of hepatitis C virus patients develop at least an autoimmune extra-hepatic disorder presumably due to the interaction between hepatitis C virus E2 envelope protein and B lymphocyte Cluster of Differentiation-81 receptor. In addition, the same interaction is responsible for the production of different serum non-organ-specific antibodies. The clinical significance of the latter phenomenon has not been fully understood except for the presence of liver kidney microsome-1 antibody, which is linked to a molecular mimicry between the cytochrome enzyme CYP2D6, primarily expressed in the liver, and hepatitis C virus proteins in genetically predisposed subjects.
Actually, no data are available about the prevalence and clinical significance of serum non-organ-specific antibodies in hepatitis C virus patients treated with second generation direct-acting antivirals.
- Conditions
- Viral Hepatitis C, Therapy Adverse Effect
- Being tested
- Non-organ-specific Ab positive, Non-organ-specific Ab negative
- Keywords
- hepatitis C virus infection, non-organ-specific antibodies, prognostic value, sustained virological response
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-organ-specific Ab positiveBiological
Also called direct-acting antiviral agents
Antiviral administration and evaluation of SVR24 and side effects
Non-organ-specific Ab negativeBiological
direct-acting antiviral agents
| Study group | Role | What they receive |
|---|---|---|
| Non-organ-specific Ab positive | Patients who had detectable circulating autoantibodies before treatment with antivirals. Receives: Biological: Non-organ-specific Ab positive | |
| Non-organ-specific Ab negative | Patients who did not have detectable circulating autoantibodies before treatment with antivirals. Receives: Biological: Non-organ-specific Ab negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response
Evaluation of HCV-RNA levels
Measured: 24 weeks after the end of antiviral therapy
Secondary outcomes (2)
Disappearance of non-organ-specific antibodies
Evaluation of anti nuclear antibodies, anti smooth muscle antibodies, liver kidney microsome antibodies
Measured: 24 weeks after the end of antiviral therapy
Side effects
Clinical manifestations and laboratory alterations
Measured: 24 weeks after the end of antiviral therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 Jul 2015
- Primary completion31 Aug 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Viral Hepatitis CStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 191 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Barone, University of Bari
- Investigators
- Alfredo Di Leo, MD, PhD, Study chair, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566966
- Sponsor's protocol ID
- Policlinic Hospital 3, Bari
- Acronym
- BIOEPA
- Status last verified
- Dec 2023
- First submitted
- 11 Jun 2018
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It depends on the possibility to merge similar data and produce a multicentric study
Publications
Shahini E, Iannone A, Romagno D, Armandi A, Carparelli S, Principi M, Viggiani MT, Ierardi E, Di Leo A, Barone M. Clinical relevance of serum non-organ-specific antibodies in patients with HCV infection receiving direct-acting antiviral therapy. Aliment Pharmacol Ther. 2018 Nov;48(10):1138-1145. doi: 10.1111/apt.14999.
PubMed 30375693
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of Serum Non-organ-specific Antibodies in Hepatitis C Virus Patients Receiving Direct-acting Antiviral Therapy
- ClinicalTrials.gov ID
- NCT03566966
- Acronym / sponsor ID
- BIOEPA / Policlinic Hospital 3, Bari
- Conditions
- Viral Hepatitis C, Therapy Adverse Effect
- Keywords
- hepatitis C virus infection, non-organ-specific antibodies, prognostic value, sustained virological response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 25 Jun 2018 (actual)
- 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.
The investigators assessed non-organ-specific antibodies before and 24 weeks after the end of therapy with direct-acting antivirals, in order to better clarify the clinical relevance of these antibodies in terms of treatment response and prognostic value.
To achieve this goal patients with hepatitis C virus related advanced liver disease, with detectable circulating autoantibodies on at least two determinations before treatment, were enrolled.
Detailed description
About 40-70% of hepatitis C virus patients develop at least an autoimmune extra-hepatic disorder presumably due to the interaction between hepatitis C virus E2 envelope protein and B lymphocyte Cluster of Differentiation-81 receptor. In addition, the same interaction is responsible for the production of different serum non-organ-specific antibodies. The clinical significance of the latter phenomenon has not been fully understood except for the presence of liver kidney microsome-1 antibody, which is linked to a molecular mimicry between the cytochrome enzyme CYP2D6, primarily expressed in the liver, and hepatitis C virus proteins in genetically predisposed subjects.
Actually, no data are available about the prevalence and clinical significance of serum non-organ-specific antibodies in hepatitis C virus patients treated with second generation direct-acting antivirals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-organ-specific Ab positive | – | Biological: Non-organ-specific Ab positivePatients who had detectable circulating autoantibodies before treatment with antivirals. |
| Non-organ-specific Ab negative | – | Biological: Non-organ-specific Ab negativePatients who did not have detectable circulating autoantibodies before treatment with antivirals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Caucasian patients affected by chronic hepatitis C virus infection who were consecutively admitted as outpatients to the Gastroenterology Unit, Policlinic Hospital, Bari, Italy, from July 2015-August 2016 to receive a treatment with second generation direct-acting antivirals.
Key inclusion criteria (1 listed)
- HCV positive patients Presence of advanced liver fibrosis Eligibility to the treatment with direct-acting antiviral therapy.
Key exclusion criteria (1 listed)
- History of autoimmune hepatitis and/or cholangitis Evidence of active hepatocellular carcinoma Human immunodeficiency virus coinfection Hepatitis B virus coinfection.
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 |
|---|---|---|
| Non-organ-specific Ab positiveAlso: direct-acting antiviral agentsAntiviral administration and evaluation of SVR24 and side effects | Biological | Non-organ-specific Ab positive |
| Non-organ-specific Ab negativedirect-acting antiviral agents | Biological | Non-organ-specific Ab negative |
Primary outcome
Sustained virological response
Time frame: 24 weeks after the end of antiviral therapy
Evaluation of HCV-RNA levels
2 secondary outcomes
Disappearance of non-organ-specific antibodies
Time frame: 24 weeks after the end of antiviral therapy
Side effects
Time frame: 24 weeks after the end of antiviral therapy
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 5 Dec 2023.
- Derived from this study: PubMed 30375693Shahini E, Iannone A, Romagno D, Armandi A, Carparelli S, Principi M, Viggiani MT, Ierardi E, Di Leo A, Barone M. Clinical relevance of serum non-organ-specific antibodies in patients with HCV infection receiving direct-acting antiviral therapy. Aliment Pharmacol Ther. 2018 Nov;48(10):1138-1145. doi: 10.1111/apt.14999.
- Individual participant dataSharing planned: Undecided. It depends on the possibility to merge similar data and produce a multicentric study
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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.
Alfredo Di Leo, MD, PhD study chair
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Hepatitis C and Therapy Adverse Effect, run by University of Bari at 1 site in Italy.
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 1 inclusion and 1 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Sustained virological response (time frame: 24 weeks after the end of antiviral therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03566966, which also lists 1 linked publication.
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 5 Dec 2023.