Completed
Incidence of Viral Hepatitis D Relapses Upon Discontinuation of Bulevirtide in Patients With Chronic Hepatitis D and Negative HDV RNA
NCT06121427
Chronic Disease, Chronic Hepatitis D
Moscow, Russia
View Trial Details
Completed
NCT Number: NCT05723068
Burden of Hepatitis D Virus (HDV) Infection in Italy
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Università degli Studi di Bari Aldo Moro, Bari, Italy
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- HBsAg-positive subjects
- 18 years or older
- anti-HD-positive
Treatment and study plan
Primary outcomes
-
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
Sponsors and collaborators
Lead sponsor
University of Turin, Italy
Other
Collaborators
- Gilead Sciences
Registry information
Official study title
Burden of Hepatitis D Virus (HDV) Infection in Italy: a Prospective/Observational Multicenter Study to Define Demographic, Clinical and Virological Features
Acronym: HDV Describe
Important dates
- Study start
- 2022
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Feb 10, 2023
- Registry last updated
- Feb 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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