Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248580
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-01-31
Brief Title:
Find HDV and Determine Its Status in Turkey
Sponsor:
Yaşar Bayındır MD
Organization:
Guven Health Group
Study Overview
Official Title:
Find HDV and Determine Its Status in Turkey SITUHDVATION
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SITUHDVATION
Brief Summary:
The aim of these study to determine the prevalence of hepatitis Delta virus HDV infections and the prognosis of HDV patients in Turkeys 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 HIVHCV 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 Turkeys 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 HIVHCV 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 HDVHCV 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 HDVHIV co-infection rate
To determine the HDVHCV 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 20000 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 20000 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 HDVHIV co-infection and HDVHCV 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 31122024 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 31012025
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
The aim of these study to determine the prevalence of HDV infections and the prognosis of HDV patients in Turkeys 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 HIVHCV 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 HDVHCV 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 HDVHIV co-infection rate
To determine the HDVHCV 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 20000 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 20000 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 HDVHIV co-infection and HDVHCV 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 31122024 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 31012025
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None