Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
20000 participants
OBSERVATIONAL
2024-03-11
2025-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus
NCT06360484
Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection
NCT06638320
The Hepatitis Delta International Network
NCT02375906
Determination of New Detection and Quantification Thresholds for Serological and Molecular Tests for Hepatitis Delta Virus (HDV) Using Capillary Blood on Blotting Paper (DBS)
NCT06649396
Standardising Care for Hepatitis Delta in the Netherlands
NCT05903742
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The aim of these study to determine the prevalence of 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 HBV, HDV, HCV, and 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.
Primary Objectives:
To reveal the status of HDV infection in Turkey within the framework of the national hepatitis elimination program by providing training to family physicians.
Second Objectives:
* To determine the frequency and type of HDV in HBV patients (HDV/HCV co-infection).
* Providing HBV, HCV, HDV and HIV awareness training to family physicians.
* To determine the virological and liver fibrosis of patients with anti-Delta positivity.
* To determine the status of patients with HBV infection who are followed by family physicians.
* To ensure that patients with HDV infection are evaluated for liver cirrhosis and liver cancer.
* To determine the HDV/HIV co-infection rate.
* To determine the HDV/HCV co-infection rate.
* Determining the vertical transmission rate in viral hepatitis and contributing to elimination by emphasizing the importance of this rate.
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.
Number of Volunteers to Participate in the Study:
It is planned to include a total of 20,000 patients with HBsAg positivity from four provinces in this study.
Study Design:
Hepatitis Delta Virus infection poses a greater risk of developing both cirrhosis and liver cancer than other viral hepatitis agents. The Southeastern Anatolia region where HDV infection is most common in Turkey. It is planned to include four provinces (Diyarbakir, Batman, Mardin and Sanliurfa) in this study. In this study, family physicians will be reached through the Health Directorate of each province.
All Family Physicians will be educated about the prognosis and complications of HBV and especially HDV infection. The training will be carried out by the Infectious Diseases or Gastroenterology specialists of that province. Anti-Delta will be tested in all patients applying to health institutions. At the same time, all HBsAg positive patients followed by each family physician will be evaluated for the presence of HDV infection. All patients with anti-Delta positivity will be tested for HIV and HCV to determine their HDV/HIV co-infection and HDV/HCV co-infection status. Simultaneously, the liver fibrosis of patients with Anti-Delta positivity will be evaluated by the fibroscan method. Fibrosis-4 (FIB-4) and Child Pugh scoring will be performed on all patients simultaneously.
After receiving ethics committee approval for this study, the data collection process for family physicians' training and follow-up patients will be completed between April and July 2024. In total, it is anticipated to reach 250 Family Physicians in the entire region. In addition, demographic characteristics of HDV patients will be determined by reaching the Infectious Diseases and Gastroenterology Centers in four provinces. A five-question survey would be organized for all family physicians before and after the training in order to measure their knowledge level and evaluate the contribution of the training. This survey will be applied and analyzed via Slido.
After determining the biochemical and virological status of all HDV infections detected in four provinces, fibrosis of the liver will be measured with Fibroscan and FIB-4, which are non-invasive methods. As a result of the study, it is aimed to diagnose an estimated 1000 HDV-infected patients and score their liver fibrosis. It is aimed to complete the biochemical, virological, demographic and liver fibrosis status and statistical analyzes of all HDV-infected patients by 31.12.2024. The status of all patients in need of treatment or transplantation will be determined and their follow-up and treatment will be carried out in line with the recommendations of international and national treatment guidelines. The writing phase of all analyzed data will be completed and finalized by 31.01.2025.
One of the important reasons why both hepatitis B infection (HBV) and HDV infections are common is related to the fact that until recently vertical transmission was an important risk factor.
Both the diagnostic approach and follow-up and effective treatment options for HDV infections are still limited. It is also clearly known that HDV infection carries a higher risk of hepatocellular carcinoma (HCC) and cirrhosis than HBV infection. It is known that 90% of patients with viral hepatitis origin who are transplant candidates in our country have HDV infection.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Family Physicians
1\. 250 Family Physicians
No interventions assigned to this group
HDV Screening
2\. 20,000 HBsAg positive patients
Anti Delta
Anti Delta by ELISA
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anti Delta
Anti Delta by ELISA
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Being HBsAg positive for at least six months
* Being a citizen of the Republic of Türkiye
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
UNKNOWN
Gilead Sciences
INDUSTRY
Yaşar Bayındır, MD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yaşar Bayındır, MD
Chief Physician, Prof. Dr., M.D.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mustafa Kemal Çelen, MD
Role: PRINCIPAL_INVESTIGATOR
Dicle University, Medical Faculty, Department of Infectious Diseases
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guven Hospital
Ankara, , Turkey (Türkiye)
Dicle University, Faculty of Medicine
Diyarbakır, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Mustafa Kemal Çelen, MD
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Guven Health Group
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.