Trial Title:
Find HDV and Determine Its Status in Turkey
NCT ID:
NCT06248580
Condition:
Chronic Hepatitis D Infection
Fibrosis, Liver
Hepatocellular Carcinoma
Cirrhosis, Liver
Transmission Vertical
Conditions: Official terms:
Hepatitis D
Hepatitis D, Chronic
Carcinoma, Hepatocellular
Hepatitis
Hepatitis, Chronic
Liver Cirrhosis
Fibrosis
Conditions: Keywords:
Chronic hepatitis D
Hepatocellular Carcinoma
Liver Cirrhosis
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Anti Delta
Description:
Anti Delta by ELISA
Arm group label:
HDV Screening
Other name:
Fibroscan
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.
Detailed description:
Study Objectives:
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Adults (Age≥18)
- Being HBsAg positive for at least six months
- Being a citizen of the Republic of Türkiye
Exclusion Criteria:
- There are no exclusion criteria in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Guven Hospital
Address:
City:
Ankara
Zip:
06850
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Yaşar Bayındır, MD
Phone:
00905323659909
Email:
yasarb44@hotmail.com
Investigator:
Last name:
Mustafa Kemal Çelen, MD
Email:
Principal Investigator
Investigator:
Last name:
Yasar Bayındır, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yeşim Taşova, MD
Email:
Sub-Investigator
Investigator:
Last name:
Çiğdem Mermutluoğlu, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yakup Demir, MD
Email:
Sub-Investigator
Facility:
Name:
Dicle University, Faculty of Medicine
Address:
City:
Diyarbakır
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Mustafa Celen, MD
Phone:
00905336207022
Email:
mkcelen@hotmail.com
Contact backup:
Last name:
Cigdem Mermutluoglu, MD
Phone:
00905052252700
Email:
cigdemmermut@gmail.com
Start date:
March 11, 2024
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Yaşar Bayındır, MD
Agency class:
Other
Collaborator:
Agency:
SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
Agency class:
Other
Collaborator:
Agency:
Gilead Sciences
Agency class:
Industry
Source:
Guven Health Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06248580
