An observational study in Chronic Hepatitis D, sponsored by University of Turin, Italy. Completed at 36 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by University of Turin, Italy · Observational
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.
43 studies on the registry are indexed under Hepatitis D, Chronic; 9 are open to participants now.
This study's enrollment of 515 is above the median of 285 across 10 observational studies indexed under Hepatitis D, Chronic.
Browse Hepatitis D, Chronic studies →University of Turin, Italy is the lead sponsor of 214 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Demographic characteristics of HDV-infected patients
Demographic characteristics: age, sex, height, weight, nationality. HDV means hepatitis D virus
Time frame: 1 year
Epidemiologic characteristics of HDV-infected patients
Risk factors for infection. HDV means hepatitis D virus
Time frame: 1 year
Serum alanine aminotransferase concentration values in HDV-infected patients
HDV means hepatitis D virus
Time frame: 1 year
Blood platelet count in HDV-infected patients
HDV means hepatitis D virus
Time frame: 1 year
Serum albumin concentration values in HDV-infected patients
HDV means hepatitis D virus
Time frame: 1 year
Serum total bilirubin concentration values in HDV-infected patients
HDV means hepatitis D virus
Time frame: 1 year
Serum anti-liver-kidney microsomal antibodies titer in HDV-infected patients
HDV means hepatitis D virus
Time frame: 1 year
Proportion of patients with detectable HDV RNA among seropositive anti-HDV patients
HDV means hepatitis D virus
Time frame: 1 year
Serum HDV RNA levels in HDV-infected patients
HDV means hepatitis D virus
Time frame: 1 year
Proportion of HDV genotypes among patients with detectable HDV RNA
HDV means hepatitis D virus
Time frame: 1 year
Proportion of patients with detectable HBV DNA among seropositive anti-HDV
HBV means hepatitis B virus. HDV means hepatitis D virus
Time frame: 1 year
Serum HBV DNA levels in HDV-infected patients
HBV means hepatitis B virus. HDV means hepatitis D virus
Time frame: 1 year
Proportion of HBV genotypes among patients with detectable HBV DNA
HBV means hepatitis B virus
Time frame: 1 year
HBsAg concentration levels in HDV-infected patients
HBsAg means hepatitis B surface antigen. HDV means hepatitis D virus
Time frame: 1 year
HBcrAg concentration levels in HDV-infected patients
HBcrAg means hepatitis B core-related antigen. HDV means hepatitis D virus
Time frame: 1 year
Proportion of patients with liver cirrhosis among seropositive anti-HDV
HDV means hepatitis D virus
Time frame: 1 year
Liver stiffness values in HDV-infected patients
HDV means hepatitis D virus
Time frame: 1 year
Proportion of patients with hepatocellular carcinoma among seropositive anti-HDV
HDV means hepatitis D virus
Time frame: 1 year
Proportion of patients treated with antiviral therapy among seropositive anti-HDV
HDV means hepatitis D virus
Time frame: 1 year
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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