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Completed

NCT Number: NCT06360484

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

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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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Center for Gastrointestinal and Liver Diseases

Khartoum, 15004, Sudan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients with HIV or HCV co-infection

Treatment and study plan

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.

Primary outcomes

  1. the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases.

    Time frame: June 2022 - September 2022

    to ascertain the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases.

Sponsors and collaborators

Lead sponsor

National Center for Gastroentestinal and Liver Disease

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

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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