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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatitis D

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Lai Wei, MD; Phone Number: +86-10 5611 8881; Email: weilai@mail.tsinghua.edu.cn
• Study Contact Backup: Name: Feng Xue; Phone Number: +86- 18810799293; Email: xuef21@mails.tsinghua.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100015
      • Bejing Tsinghua Changgung Hospital
      • Contact: Lai Wei, MD; Phone Number: (+86)10 5611 8881; Email: weilai@mail.tsinghua.edu.cn
      • Contact: Feng Xue; Phone Number: (+86)18810799293; Email: xuef21@mails.tsinghua.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HDV-infected individuals with a positive HDV RNA test result

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single Group Assignment

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

Collaborators and Investigators

• Sponsor: Lai Wei

Publications and helpful links

General Publications

• Lok AS, Negro F, Asselah T, Farci P, Rizzetto M. Endpoints and New Options for Treatment of Chronic Hepatitis D. Hepatology. 2021 Dec;74(6):3479-3485. doi: 10.1002/hep.32082. Epub 2021 Sep 16. Review.
• Rizzetto M, Hamid S, Negro F. The changing context of hepatitis D. J Hepatol. 2021 May;74(5):1200-1211. doi: 10.1016/j.jhep.2021.01.014. Epub 2021 Jan 20. Review.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): June 1, 2028
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: June 26, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: hepatitis D virus
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis D
• Other Study ID Numbers: 22201-4-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No