Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China

Study Overview
=================
Brief Summary
-----------------
This is a retrospective, prospective, noninterventive, multicenter registry study. Patients diagnosed with HDV infection (based on positive HDV RNA) were included in this study and were followed up for at least 5 years to evaluate their disease progression and clinical outcomes (including death, liver transplantation, hepatocellular carcinoma [hcc], liver decompensation, and cirrhosis) during the 5-year follow-up period. All patients were followed up at least once a year after they were included in the study. It was in 2016 HDV infection first reported in China. Since January 1, 2016, all patients diagnosed with HDV infection can be enrolled in this study and evidence confirming the diagnosis (including but not limited to HDV RNA test reports and medical records, etc.) must be delivered. The main test results (including serum HDV RNA, ALT, and tests to determine the presence of liver cirrhosis, decompensation of liver function, and liver cancer such as B-ultrasound and FibroScan) of these patients each year from diagnosis to enrollment should be collected and filled in the case report form (CRF). Follow-up data of patients with serum anti-HDV positive and HDV RNA negative can be recorded and followed up on this platform, with informed consent of the patients is required. Patients whose serum HBV RNA turn positive during the follow-up period will be included in the follow-up cohort of the study.

Official Title
-----------------
Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China

Conditions
-----------------
Hepatitis D

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 or above, both sex; Evidence of a positive test for HDV RNA can be provided on or before the enrollment date; Able to sign written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Group Assignment<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of death of patients infected with HDV during 5-year follow-up | HDV means hepatitis D virus | 5 years | 
| The incidence of liver transplantation of patients infected with HDV during 5-year follow-up | HDV means hepaitis D virus | 5 years | 
| The incidence of hepatocellular carcinoma of patients infected with HDV during 5-year follow-up | HDV means hepaitis D virus | 5 years | 
| The incidence of liver decompensation of patients infected with HDV during 5-year follow-up | liver decompensation means ascites, variceal bleeding, or hepatic encephalopathy | 5 years | 
| The incidence of cirrhosis of patients infected with HDV during 5-year follow-up | Patients who developed cirrhosis in the absence of cirrhosis at baseline by liver biopsy or noninvasive testing | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic characteristics of HDV-infected individuals using baseline data | Demographic characteristics: age, sex, height, weight, nationality, main residence, economic level. | 1 year | 
| Epidemiological characteristics of HDV-infected individuals using baseline data | Risk factors for infection/possible route of infection, HDV genotype | 1 year | 
| Serum HDV RNA levels of patients infected with HDV | HDV means hepaitis D virus | 5 years | 
| Serum HBV DNA levels of patients infected with HDV | HBV means hepaitis B virus, HDV means hepaitis D virus | 5 years | 
| HBsAg concentration levels of patients infected with HDV | HBsAg means Hepatitis B surface antigen，HDV means hepaitis D virus | 5 years | 
| Serum alanine aminotransferase concentration levels of patients infected with HDV | HDV means hepaitis D virus | 5 years | 
| Serum total bilirubin concentration levels of patients infected with HDV | HDV means hepaitis D virus | 5 years | 
| Serum albumin levels concentration levels of patients infected with HDV | HDV means hepaitis D virus | 5 years | 
| Child-Pugh scores of patients infected with HDV | The Child-Pugh classification is a universal scoring system of the degree of liver failure in patients with cirrhosis. Variables measured by this system include ascites, encephalopathy, serum albumin, bilirubin, and prothrombin time. Traditionally, the Child-Pugh class (A, B, or C) has been used as a predictive index for operative mortality rate in adult patients undergoing portosystemic shunting procedures. The estimated 1- and 5-year survival rates are 95% and 75% for patients with Child-Pugh class B, and 85% and 50% for patients with Child-Pugh class C. | 5 years | 
| The incidence of death of chronic HDV-infected patients with persistently normal ALT | HDV means hepaitis D virus, ALT means alanine aminotransferase | 5 years | 
| The incidence of liver transplantation of chronic HDV-infected patients with persistently normal ALT | HDV means hepaitis D virus, ALT means alanine aminotransferase | 5 years | 
| The incidence of hepatocellular carcinoma (HCC) of chronic HDV-infected patients with persistently normal ALT | HDV means hepaitis D virus, ALT means alanine aminotransferase | 5 years | 
| The incidence of liver decompensation of chronic HDV-infected patients with persistently normal ALT | HDV means hepaitis D virus, ALT means alanine aminotransferase | 5 years | 
| The incidence of cirrhosis of chronic HDV-infected patients with persistently normal ALT | HDV means hepaitis D virus, ALT means alanine aminotransferase | 5 years | 
| The proportion of patients with HDV RNA negative conversion of patients receiving antiviral therapies | HDV RNA negative conversion means HDV RNA< lower limit of quantification（LLOQ） | 5 years | 
| The proportion of patients with a >2lg IU/mL HDV RNA decline of patients receiving antiviral therapies | The proportion of patients with a HDV RNA decrease of greater than 2log IU/mL | 5 years | 
| Changes in serum HDV RNA during treatment and after discontinuation | HDV means hepatitis D virus | 5 years | 
| The proportion of patients with ALT normalization of patients receiving antiviral therapies | ALT means alanine aminotransferase，ALT normalization means ALT <ULN | 5 years | 
| Combined response rate of patients with antiviral therapy | Combined response means HDV RNA <LLOQ and ALT<ULN | 5 years | 
| Number of patients with abnormal laboratory values and/or adverse events that are related to antiviral treatment | Number of patients with adverse events, sever adverse events, abnormal laboratory parameters, and drug combinations | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis D virus