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

NCT06360484 | Completed

• 1 other identifier: PrevelanceHDVSudan
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hepatitis B; Hepatitis D; Viral Hepatitis

Outcome Measures

Primary Outcomes (1)

• 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

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study was conducted between June and September 2022, involving patients aged 16 years and above with hepatitis B virus infection. Patients attending the liver clinic or admitted at Ibn Sina Specialized Hospital were included, while those with HIV and HCV co-infection were excluded.

You may qualify if:

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

You may not qualify if:

• patients with HIV or HCV co-infection

Sponsors & Collaborators

• National Center for Gastroentestinal and Liver Disease: lead

Study Sites (1)

National Center for Gastrointestinal and Liver Diseases

Khartoum, 15004, Sudan

Location

MeSH Terms

Conditions

Hepatitis B; Hepatitis D

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

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

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: June 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 10, 2022
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

SU (1)