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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
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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

In context

Hepatitis B

1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.

This study's enrollment of 90 is below the median of 365 across 251 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

National Center for Gastroentestinal and Liver Disease is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients aged 16 years and above
  • with virus infection

Exclusion criteria

Exclusion Criteria:

  • patients with or co-infection
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

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.

06

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

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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.

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Discussion

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