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NCT06360484 Clinical Trial

Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus

Hepatitis B Clinical Trial

Official title:
Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus (HBV), A Cross-Sectional Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06360484
Other study ID # PrevelanceHDVSudan
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date September 10, 2022

Study information
Verified date April 2024
Source National Center for Gastroentestinal and Liver Disease
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: Sudan has a high prevalence of hepatitis B surface antigen (HBsAg), exceeding 8%. The prevalence of hepatitis B varies across different regions of Sudan, ranging from 6.8% in central Sudan to as high as 26% in southern Sudan. Hepatitis B virus (HBV) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Hepatitis D virus (HDV) relies on HBV for replication and can accelerate the progression of HBV-related liver diseases, leading to more severe outcomes. This study aims to determine the prevalence of HDV infection among Sudanese patients with HBV-related liver diseases and to investigate the clinical characteristics of patients with HBV/HDV co-infection. Design/Method: This descriptive cross-sectional hospital-based study was conducted at Ibn Sina Specialized Hospital in Sudan between June and September 2022. Ninety HBV patients aged 16 years and above were included. Patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. Investigations included liver function tests, abdominal ultrasounds, and ELISA for Ant-HDV-IgG

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date September 10, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - patients aged 16 years and above - with hepatitis B virus infection Exclusion Criteria: - patients with HIV or HCV co-infection

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• investigations for Hepatitis D virus
Investigations included liver function tests, abdominal ultrasounds to identify features of chronic liver disease, and evidence of decompensation. ELISA for Ant-HDV-IgG was conducted.

Locations
Country Name City State
Sudan National Center for Gastrointestinal and Liver Diseases Khartoum

Sponsors (1)
Lead Sponsor Collaborator
National Center for Gastroentestinal and Liver Disease

Country where clinical trial is conducted

Sudan, 

Outcome
Type Measure Description Time frame Safety issue
Primary the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases. to ascertain the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases. June 2022 - September 2022
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