CClinicalTrials.gg
CompletedNCT06360484Updated Apr 11, 2024

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

An observational study in Hepatitis B, Hepatitis D and Viral Hepatitis, sponsored by National Center for Gastroentestinal and Liver Disease. Completed at 1 site in Sudan. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.

Sponsored by National Center for Gastroentestinal and Liver Disease · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
90
Ages
16 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Hepatitis B
  • Hepatitis D
  • Viral Hepatitis
03

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with HIV or HCV co-infection
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
90 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testinvestigations 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.

05

What researchers measure

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.

    Time frame: June 2022 - September 2022

06

Study locations

1 site
  • National Center for Gastrointestinal and Liver Diseases
    Khartoum, 15004, Sudan
07

Registry details

Key details

Study ID
NCT06360484
Lead sponsor
National Center for Gastroentestinal and Liver Disease
Responsible party
Sponsor
First posted
Apr 11, 2024
Start date
Jun 1, 2022
Primary completion
Sep 1, 2022
Completion
Sep 10, 2022
Last update
Apr 11, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion