Chronic Hepatitis DHDV DescribeNCT05723068
Burden of Hepatitis D Virus (HDV) Infection in Italy
An observational study of Chronic Hepatitis D, run by University of Turin, Italy at 36 sites in Italy.
Trial summary
The circulation of the Hepatitis D Virus (HDV) has considerably diminished in Italy, secondary to the control of the Hepatitis B Virus (HBV) with vaccination; this has led to the perception that HDV is vanishing and has reduced attention to the diagnosis of Hepatitis D. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis D
- How many people
- 515 participants
- Where
- 36 sitesItaly
- Study dates
- 24 Aug 2022to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited in a Country-wide coordinated network of national medical centers. The network will include hepatology, infectious disease and internal medicine centers that historically care for patients with viral liver disease, located in the 12 major regions of Italy.
Who may be able to join
- HBsAg-positive subjects
- 18 years or older
- anti-HD-positive
Who cannot join
None listed.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Italy36 sites
Università degli Studi di Bari Aldo Moro
Bari
Gastroenterology Hepatology and Transplantation, ASST Bergamo
Bergamo
Malattie Infettive, ASST Bergamo
Bergamo
Dipartimento di Scienze Mediche e Chirurgiche, Università degli Studi di Bologna
Bologna
Dipartimento di Scienze Cliniche e Sperimentali, Università degli Studi di Brescia
Brescia
UOC Malattie Infettive e Tropicali, A.O. S Anna e S Sebastiano
Caserta
UOS Epatologia "G. Rodolico-San Marco"
Catania
UOC Medicina Interna Ospedaliera, Policlinico "Mater Domini"
Catanzaro
Dipartimento di Medicina Clinica e Sperimentale, Università degli Studi di Foggia
Foggia
S.C. Malattie Infettive, E.O. Ospedali Galliera
Genova
UOC Malattie Infettive, Ospedale Paolo Borsellino di Marsala
Marsala
A.O.U. Policlinico G. Martino di Messina, Università di Messina
Messina
Dipartimento di Malattie Infettive e Centro Epatopatie, ASST Grande Ospedale Metropolitano Niguarda
Milan
Dipartimento di Malattie Infettive, ASST Fatebenefratelli - Ospedale Luigi Sacco
Milan
UOC Gastroenterologia e Epatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano
Milan
UOC di Medicina Interna Metabolica, AOU di Modena e Università di Modena e Reggio
Modena
Dipartimento di Malattie Infettive, Ospedale D. Cotugno
Naples
Dipartimento di Medicina di Precisione, Università della Campania "Luigi Vanvitelli"
Naples
Dipartimento di Medicina e Chirurgia, Università degli Studi di Napoli Federico II
Naples
Dipartimento di Medicina Interna, Università della Campania "Luigi Vanvitelli"
Naples
Dipartimento di Medicina Traslazionale, Università del Piemonte Orientale
Novara
UOC Malattie Infettive e Tropicali, Azienda Ospedale-Università di Padova
Padova
Dipartimento di Promozione della Salute, Materno-Infantile di Medicina Interna e Specialistica di Eccellenza "G. D'Alessandro", Università degli Studi di Palermo
Palermo
UOC di Malattie Infettive, Università di Parma
Parma
Dipartimento di Medicina Clinica e Sperimentale, Università di Pisa
Pisa
UOC Malattie Infettive, Grande Ospedale Metropolitano "Bianchi - Melacrino - Morelli"
Reggio Calabria
Malattie Infettive Roma 2
Roma
Ospedale S. Andrea
Roma
Policlinico Gemelli
Roma
UOC Malattie Infettive Epatologia, IRCCS Lazzaro Spallanzani
Roma
Unità di Gastroenterologia ed Endoscopia Digestiva, IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo
UOC Malattie Infettive
Syracuse
Clinica Universitaria Malattie Infettive, Ospedale Amedeo di Savoia
Torino
Unit of Gastroenterology, University of Turin
Torino
Unità di Epatologia e Trapianti di Fegato, Università degli Studi di Udine
Udine
UO Malattie Infettive, Azienda Ospedaliera Universitaria Integrata Verona
Verona
About this study
Official title: Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features
The circulation of the Hepatitis D Virus (HDV) has considerably diminished in Italy, secondary to the control of the Hepatitis B Virus (HBV) with vaccination; this has led to the perception that HDV is vanishing and has reduced attention to the diagnosis of Hepatitis D. However, migratory fluxes from HDV endemic areas, fostered by labour-forces globalization, are increasingly reconstituting the reservoir of HDV in the country and hepatitis D has not yet vanished in native Italians but will remain an important medical issue for several years to come. As the epidemiologic and clinical features of HDV infection in migrant communities are largely unknown and the features of native Italians with long standing HDV infections have not been updated, this project intends to establish the contemporary epidemiological and medical context of HDV in immigrants in Italy and to determine the clinical characteristics and needs of the residual cohort of native HDV Italians, through the analysis of all HDV cases recruited in 12 months in a coordinated network of 35 Italian medical centers. The data will provide an appraisal of the burden of hepatitis D in the country and of its impact on the National Health System. They will present the paradigm of the current trend of HDV infection in high-income countries in the world.
- Conditions
- Chronic Hepatitis D
- Medical subject headings
- Hepatitis D, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic hepatitis D | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic characteristics of HDV-infected patients
Demographic characteristics: age, sex, height, weight, nationality. HDV means hepatitis D virus
Measured: 1 year
Epidemiologic characteristics of HDV-infected patients
Risk factors for infection. HDV means hepatitis D virus
Measured: 1 year
Serum alanine aminotransferase concentration values in HDV-infected patients
HDV means hepatitis D virus
Measured: 1 year
Blood platelet count in HDV-infected patients
HDV means hepatitis D virus
Measured: 1 year
Serum albumin concentration values in HDV-infected patients
HDV means hepatitis D virus
Measured: 1 year
Serum total bilirubin concentration values in HDV-infected patients
HDV means hepatitis D virus
Measured: 1 year
Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients
HDV means hepatitis D virus
Measured: 1 year
Proportion of patients with detectable HDV RNA among seropositive anti-HDV patients
HDV means hepatitis D virus
Measured: 1 year
Serum HDV RNA levels in HDV-infected patients
HDV means hepatitis D virus
Measured: 1 year
Proportion of HDV genotypes among patients with detectable HDV RNA
HDV means hepatitis D virus
Measured: 1 year
Proportion of patients with detectable HBV DNA among seropositive anti-HDV
HBV means hepatitis B virus. HDV means hepatitis D virus
Measured: 1 year
Serum HBV DNA levels in HDV-infected patients
HBV means hepatitis B virus. HDV means hepatitis D virus
Measured: 1 year
Proportion of HBV genotypes among patients with detectable HBV DNA
HBV means hepatitis B virus
Measured: 1 year
HBsAg concentration levels in HDV-infected patients
HBsAg means hepatitis B surface antigen. HDV means hepatitis D virus
Measured: 1 year
HBcrAg concentration levels in HDV-infected patients
HBcrAg means hepatitis B core-related antigen. HDV means hepatitis D virus
Measured: 1 year
Proportion of patients with liver cirrhosis among seropositive anti-HDV
HDV means hepatitis D virus
Measured: 1 year
Liver stiffness values in HDV-infected patients
HDV means hepatitis D virus
Measured: 1 year
Proportion of patients with hepatocellular carcinoma among seropositive anti-HDV
HDV means hepatitis D virus
Measured: 1 year
Proportion of patients treated with antiviral therapy among seropositive anti-HDV
HDV means hepatitis D virus
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start24 Aug 2022
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis DStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Mario Rizzetto, MD, Principal investigator, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723068
- Sponsor's protocol ID
- IN-IT-980-6382
- Acronym
- HDV Describe
- Status last verified
- Feb 2025
- First submitted
- 11 Jan 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features
- ClinicalTrials.gov ID
- NCT05723068
- Acronym / sponsor ID
- HDV Describe / IN-IT-980-6382
- Conditions
- Chronic Hepatitis D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Feb 2023 (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 circulation of the Hepatitis D Virus (HDV) has considerably diminished in Italy, secondary to the control of the Hepatitis B Virus (HBV) with vaccination; this has led to the perception that HDV is vanishing and has reduced attention to the diagnosis of Hepatitis D. However, migratory fluxes from HDV endemic areas, fostered by labour-forces globalization, are increasingly reconstituting the reservoir of HDV in the country and hepatitis D has not yet vanished in native Italians but will remain an important medical issue for several years to come. As the epidemiologic and clinical features of HDV infection in migrant communities are largely unknown and the features of native Italians with long standing HDV infections have not been updated, this project intends to establish the contemporary epidemiological and medical context of HDV in immigrants in Italy and to determine the clinical characteristics and needs of the residual cohort of native HDV Italians, through the analysis of all HDV cases recruited in 12 months in a coordinated network of 35 Italian medical centers. The data will provide an appraisal of the burden of hepatitis D in the country and of its impact on the National Health System. They will present the paradigm of the current trend of HDV infection in high-income countries in the world.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic hepatitis D | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in a Country-wide coordinated network of national medical centers. The network will include hepatology, infectious disease and internal medicine centers that historically care for patients with viral liver disease, located in the 12 major regions of Italy.
Key inclusion criteria (3 listed)
- HBsAg-positive subjects
- 18 years or older
- anti-HD-positive
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic characteristics of HDV-infected patients
Time frame: 1 year
Demographic characteristics: age, sex, height, weight, nationality. HDV means hepatitis D virus
Epidemiologic characteristics of HDV-infected patients
Time frame: 1 year
Risk factors for infection. HDV means hepatitis D virus
Serum alanine aminotransferase concentration values in HDV-infected patients
Time frame: 1 year
HDV means hepatitis D virus
Blood platelet count in HDV-infected patients
Time frame: 1 year
HDV means hepatitis D virus
Serum albumin concentration values in HDV-infected patients
Time frame: 1 year
HDV means hepatitis D virus
Serum total bilirubin concentration values in HDV-infected patients
Time frame: 1 year
HDV means hepatitis D virus
Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients
Time frame: 1 year
HDV means hepatitis D virus
Proportion of patients with detectable HDV RNA among seropositive anti-HDV patients
Time frame: 1 year
HDV means hepatitis D virus
Serum HDV RNA levels in HDV-infected patients
Time frame: 1 year
HDV means hepatitis D virus
Proportion of HDV genotypes among patients with detectable HDV RNA
Time frame: 1 year
HDV means hepatitis D virus
Proportion of patients with detectable HBV DNA among seropositive anti-HDV
Time frame: 1 year
HBV means hepatitis B virus. HDV means hepatitis D virus
Serum HBV DNA levels in HDV-infected patients
Time frame: 1 year
HBV means hepatitis B virus. HDV means hepatitis D virus
Proportion of HBV genotypes among patients with detectable HBV DNA
Time frame: 1 year
HBV means hepatitis B virus
HBsAg concentration levels in HDV-infected patients
Time frame: 1 year
HBsAg means hepatitis B surface antigen. HDV means hepatitis D virus
HBcrAg concentration levels in HDV-infected patients
Time frame: 1 year
HBcrAg means hepatitis B core-related antigen. HDV means hepatitis D virus
Proportion of patients with liver cirrhosis among seropositive anti-HDV
Time frame: 1 year
HDV means hepatitis D virus
Liver stiffness values in HDV-infected patients
Time frame: 1 year
HDV means hepatitis D virus
Proportion of patients with hepatocellular carcinoma among seropositive anti-HDV
Time frame: 1 year
HDV means hepatitis D virus
Proportion of patients treated with antiviral therapy among seropositive anti-HDV
Time frame: 1 year
HDV means hepatitis D virus
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 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Mario Rizzetto, MD principal investigator
University of Turin, Italy
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis D, run by University of Turin, Italy at 36 sites 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 3 inclusion and 0 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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites 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?
Demographic characteristics of HDV-infected patients (time frame: 1 year). The study lists 19 primary outcomes in all. 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 5 Feb 2025.