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

NCT06360484 — Completed, 90 participants, National Center for Gastroentestinal and Liver Disease

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

Registry	NCT06360484
Status	Completed
Study type	Observational
Enrollment	90 (Actual)
Sponsor	National Center for Gastroentestinal and Liver Disease (Other)
Conditions	Hepatitis B, Hepatitis D, Viral Hepatitis
Interventions	investigations for Hepatitis D virus (Diagnostic test)
Dates	start 2022-06-01, primary completion 2022-09-01, completion 2022-09-10, first posted 2024-04-11, last updated 2024-04-11
Locations	1 site in Sudan

-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

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+Arms and interventions

investigations for Hepatitis D virus (Diagnostic test): 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.

+Outcome measures

Primary outcomes

the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases. [June 2022 - September 2022]: to ascertain the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases.

+Eligibility

Sex: All, ages: 16 Years to any

Inclusion Criteria:

* patients aged 16 years and above
* with hepatitis B virus infection

Exclusion Criteria:

* patients with HIV or HCV co-infection

+Locations (1)

Facility	City	Country	Status
National Center for Gastrointestinal and Liver Diseases	Khartoum	Sudan