Find HDV and Determine Its Status in Turkey

NCT06248580 | Recruiting

• 1 other identifier: Guven Health Group
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of these study to determine the prevalence of hepatitis Delta virus (HDV) infections and the prognosis of HDV patients in Turkey's southeast. The investigators intend to arrange training sessions for 250 family physicians in Diyarbakir, Batman, Mardin, and Sanliurfa in order to determine those goals. The investigators will talk about diagnosing hepatitis B virus (HBV), HDV, hepatitis C virus (HCV), and Human Immunodeficiency virus (HIV) infections during these events. To ensure that patients with simultaneous HDV infection are evaluated for HIV/HCV and to detect liver fibrosis with a non-invasive method.

Conditions

Chronic Hepatitis D Infection; Fibrosis, Liver; Hepatocellular Carcinoma; Cirrhosis, Liver; Transmission Vertical

Keywords

Chronic hepatitis D; Hepatocellular Carcinoma; Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• The frequency of HDV in certain regions of Southern Anatolia

  The primary endpoint of this study is to determine the frequency of HDV in certain regions of Southern Anatolia, and the virological and liver fibrosis status of patients with HDV infection.

  01.04.2024-30.09.2024

Secondary Outcomes (1)

• The rate of HIV and HCV co-infection in HDV positive patients

  01.04.2024-30.09.2024

Study Arms (2)

Family Physicians

1\. 250 Family Physicians

HDV Screening

2\. 20,000 HBsAg positive patients

Diagnostic Test: Anti Delta

Interventions

Anti Delta DIAGNOSTIC_TEST

Anti Delta by ELISA

Also known as: Fibroscan

HDV Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

To ensure that 20,000 patients with HBsAg positivity in Diyarbakir, Mardin, Batman and Sanliurfa are evaluated for HDV infection. To investigate HDV positive patients for liver fibrosis using the fibroscan method.

You may qualify if:

• Adults (Age≥18)
• Being HBsAg positive for at least six months
• Being a citizen of the Republic of Türkiye

Sponsors & Collaborators

• Yaşar Bayındır, MD: lead
• SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY: collaborator
• Gilead Sciences: collaborator

Study Sites (2)

Guven Hospital

Ankara, 06850, Turkey (Türkiye)

RECRUITING

Dicle University, Faculty of Medicine

Diyarbakır, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Carcinoma, Hepatocellular; Hepatitis D, Chronic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Hepatitis D; Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes

Study Officials

• Mustafa Kemal Çelen, MD

  Dicle University, Medical Faculty, Department of Infectious Diseases

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaşar Bayındır, MD

CONTACT

00905323659909; yasar.bayindir@guven.com.tr

Mustafa Kemal Çelen, MD

CONTACT

00905336207022

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 13 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Prof. Dr., M.D.

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: March 11, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)