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

NCT05451082 | Not Yet Recruiting

• 1 other identifier: 22201-4-02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis D

Keywords

hepatitis D virus

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (20)

• Demographic characteristics of HDV-infected individuals using baseline data

  1 year

• Epidemiological characteristics of HDV-infected individuals using baseline data

  1 year

• Serum HDV RNA levels of patients infected with HDV

  5 years

• Serum HBV DNA levels of patients infected with HDV

  5 years

• HBsAg concentration levels of patients infected with HDV

  5 years

Study Arms (1)

Single Group Assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HDV-infected individuals with a positive HDV RNA test result

You may qualify if:

• 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.

Sponsors & Collaborators

• Lai Wei: lead

Study Sites (1)

Bejing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 100015, China

Location

Related Publications (2)

• 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. No abstract available.

  PMID: 34331781 BACKGROUND

• 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.

  PMID: 33484770 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Hepatitis D

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Lai Wei, MD

CONTACT

+86-10 5611 8881; weilai@mail.tsinghua.edu.cn

Feng Xue

CONTACT

+86- 18810799293; xuef21@mails.tsinghua.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: July 11, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)