Clinical trial NCT05451082: Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China
Official title: Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatitis D
Keywords: hepatitis D virus
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HDV-infected individuals with a positive HDV RNA test result

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.


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.

Primary outcomes:
measure: The incidence of death of patients infected with HDV during 5-year follow-up
timeFrame: 5 years
measure: The incidence of liver transplantation of patients infected with HDV during 5-year follow-up
timeFrame: 5 years
measure: The incidence of hepatocellular carcinoma of patients infected with HDV during 5-year follow-up
timeFrame: 5 years
measure: The incidence of liver decompensation of patients infected with HDV during 5-year follow-up
timeFrame: 5 years
measure: The incidence of cirrhosis of patients infected with HDV during 5-year follow-up
timeFrame: 5 years
Secondary outcomes:
measure: Demographic characteristics of HDV-infected individuals using baseline data
timeFrame: 1 year
measure: Epidemiological characteristics of HDV-infected individuals using baseline data
timeFrame: 1 year
measure: Serum HDV RNA levels of patients infected with HDV
timeFrame: 5 years
measure: Serum HBV DNA levels of patients infected with HDV
timeFrame: 5 years
measure: HBsAg concentration levels of patients infected with HDV
timeFrame: 5 years
measure: Serum alanine aminotransferase concentration levels of patients infected with HDV
timeFrame: 5 years
measure: Serum total bilirubin concentration levels of patients infected with HDV
timeFrame: 5 years
measure: Serum albumin levels concentration levels of patients infected with HDV
timeFrame: 5 years
measure: Child-Pugh scores of patients infected with HDV
timeFrame: 5 years
measure: The incidence of death of chronic HDV-infected patients with persistently normal ALT
timeFrame: 5 years
measure: The incidence of liver transplantation of chronic HDV-infected patients with persistently normal ALT
timeFrame: 5 years
measure: The incidence of hepatocellular carcinoma (HCC) of chronic HDV-infected patients with persistently normal ALT
timeFrame: 5 years
measure: The incidence of liver decompensation of chronic HDV-infected patients with persistently normal ALT
timeFrame: 5 years
measure: The incidence of cirrhosis of chronic HDV-infected patients with persistently normal ALT
timeFrame: 5 years
measure: The proportion of patients with HDV RNA negative conversion of patients receiving antiviral therapies
timeFrame: 5 years
measure: The proportion of patients with a >2lg IU/mL HDV RNA decline of patients receiving antiviral therapies
timeFrame: 5 years
measure: Changes in serum HDV RNA during treatment and after discontinuation
timeFrame: 5 years
measure: The proportion of patients with ALT normalization of patients receiving antiviral therapies
timeFrame: 5 years
measure: Combined response rate of patients with antiviral therapy
timeFrame: 5 years
measure: Number of patients with abnormal laboratory values and/or adverse events that are related to antiviral treatment
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Bejing Tsinghua Changgung Hospital
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.