Disease Loads and Status of Treatment

NCT05264272 | Unknown

• 2 other identifiers: 201904075RINA1103705906 (Dec23-2021 renew)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of study is to evaluate the current prevalence of HDV infection, and comprehensively analyze the interaction between HDV and HBV infections in the era of NAs in Taiwan. Investigators plan to set up a platform for HDV positive patients in Taiwan to invite sites or hepatologists who are interested in this field.

Conditions

Chronic Hepatitis B; Acute Hepatitis B; Hepatitis D

Keywords

hepatitis B; hepatitis D

Outcome Measures

Primary Outcomes (1)

• HDV infection prevalence

  The aim of study is to evaluate the current prevalence of HDV infection, and comprehensively analyze the interaction between HDV and HBV infections in the era of NAs in Taiwan.

  36 months

Study Arms (2)

Prospective Study

HBV/HDV positive individuals

Other: Prospective serological assays

Retrospective Study

patients positive for anti-HDV

Other: Retrospective serological assays

Interventions

Prospective serological assays OTHER

1. Investigators will measure the levels of hemogram, AST, ALT, Bilirubine-total,Platelet, ALP, rGT, Albumin, GluAC, HBA1C, Albumin, INR, AFP, Creatinine, eGFR, HBsAg, quantitative HBsAg, anti-HBc, HBeAg, anti-HBe, HBV DNA, HBV genotype, anti-HDV, HDV RNA, and HDV RNA genotype at the enrollment of the study. 2. BMI data, and Child-Pugh score (in cirrhotic patients) at the enrollment of the study. The smoking status, alcohol, coffee and green tea consumption, diabetes, family history of HCC will be collected.

Prospective Study

Retrospective serological assays OTHER

1. Investigators will measure hemogram, AST, ALT, Bilirubine-total,Platelet, ALP, rGT, Albumin, GluAC, HBA1C, Albumin, INR, AFP, Creatinine, eGFR, HBsAg, quantitative HBsAg, anti-HBc, HBeAg, anti-HBe, HBV DNA, HBV genotype, anti-HDV, HDV RNA, HDV RNA genotype BMI data, and Child-Pugh score (in cirrhotic patients) at the enrollment of the study. 2. The smoking status, alcohol, coffee and green tea consumption, diabetes, family history of HCC will be collected.

Retrospective Study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatitis B and hepatitis D patients

You may qualify if:

• Chronic HBV
• Acute HBV
• anti-HDV positive

You may not qualify if:

• Other diagnostics deemed not suitable for this study by the principal investigator

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis D; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; RNA Virus Infections

Central Study Contacts

Chun-Jen Liu, Doctor

CONTACT

+88697265107; cjliu@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 3, 2022
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)