An observational study in Hepatitis D, sponsored by Lai Wei. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-11.
Sponsored by Lai Wei · Observational
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.
63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 326 across 29 observational studies indexed under Hepatitis D.
Browse Hepatitis D studies →Lai Wei is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
HDV-infected individuals with a positive HDV RNA test result
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The incidence of death of patients infected with HDV during 5-year follow-up
HDV means hepatitis D virus
Time frame: 5 years
The incidence of liver transplantation of patients infected with HDV during 5-year follow-up
HDV means hepaitis D virus
Time frame: 5 years
The incidence of hepatocellular carcinoma of patients infected with HDV during 5-year follow-up
HDV means hepaitis D virus
Time frame: 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
Time frame: 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
Time frame: 5 years
Demographic characteristics of HDV-infected individuals using baseline data
Demographic characteristics: age, sex, height, weight, nationality, main residence, economic level.
Time frame: 1 year
Epidemiological characteristics of HDV-infected individuals using baseline data
Risk factors for infection/possible route of infection, HDV genotype
Time frame: 1 year
Serum HDV RNA levels of patients infected with HDV
HDV means hepaitis D virus
Time frame: 5 years
Serum HBV DNA levels of patients infected with HDV
HBV means hepaitis B virus, HDV means hepaitis D virus
Time frame: 5 years
HBsAg concentration levels of patients infected with HDV
HBsAg means Hepatitis B surface antigen，HDV means hepaitis D virus
Time frame: 5 years
Serum alanine aminotransferase concentration levels of patients infected with HDV
HDV means hepaitis D virus
Time frame: 5 years
Serum total bilirubin concentration levels of patients infected with HDV
HDV means hepaitis D virus
Time frame: 5 years
Serum albumin levels concentration levels of patients infected with HDV
HDV means hepaitis D virus
Time frame: 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.
Time frame: 5 years
The incidence of death of chronic HDV-infected patients with persistently normal ALT
HDV means hepaitis D virus, ALT means alanine aminotransferase
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 years
The incidence of cirrhosis of chronic HDV-infected patients with persistently normal ALT
HDV means hepaitis D virus, ALT means alanine aminotransferase
Time frame: 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）
Time frame: 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
Time frame: 5 years
Changes in serum HDV RNA during treatment and after discontinuation
HDV means hepatitis D virus
Time frame: 5 years
The proportion of patients with ALT normalization of patients receiving antiviral therapies
ALT means alanine aminotransferase，ALT normalization means ALT \<ULN
Time frame: 5 years
Combined response rate of patients with antiviral therapy
Combined response means HDV RNA \<LLOQ and ALT\<ULN
Time frame: 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
Time frame: 5 years
Plan to share: Yes
Supporting information: Clinical study report
This study is not yet recruiting, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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