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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)