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Not yet recruiting NCT05451082

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

— Observational Hepatitis D

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hepatitis D. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • The incidence of death of patients infected with HDV during 5-year follow-up [Time frame: 5 years]
  • The incidence of liver transplantation of patients infected with HDV during 5-year follow-up [Time frame: 5 years]
  • The incidence of hepatocellular carcinoma of patients infected with HDV during 5-year follow-up [Time frame: 5 years]
  • The incidence of liver decompensation of patients infected with HDV during 5-year follow-up [Time frame: 5 years]
  • The incidence of cirrhosis of patients infected with HDV during 5-year follow-up [Time frame: 5 years]
Secondary outcome measures (12)
  • Demographic characteristics of HDV-infected individuals using baseline data [Time frame: 1 year]
  • Epidemiological characteristics of HDV-infected individuals using baseline data [Time frame: 1 year]
  • Serum HDV RNA levels of patients infected with HDV [Time frame: 5 years]
  • Serum HBV DNA levels of patients infected with HDV [Time frame: 5 years]
  • HBsAg concentration levels of patients infected with HDV [Time frame: 5 years]
  • Serum alanine aminotransferase concentration levels of patients infected with HDV [Time frame: 5 years]
  • Serum total bilirubin concentration levels of patients infected with HDV [Time frame: 5 years]
  • Serum albumin levels concentration levels of patients infected with HDV [Time frame: 5 years]
  • Child-Pugh scores of patients infected with HDV [Time frame: 5 years]
  • The incidence of death of chronic HDV-infected patients with persistently normal ALT [Time frame: 5 years]
  • The incidence of liver transplantation of chronic HDV-infected patients with persistently normal ALT [Time frame: 5 years]
  • The incidence of hepatocellular carcinoma (HCC) of chronic HDV-infected patients with persistently normal ALT [Time frame: 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Bejing Tsinghua Changgung Hospital — Beijing

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. No abstract available. PMID 34331781
  • 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

Identifiers

NCT: NCT05451082 · 22201-4-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗