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Trial record 2 of 94 for:    Hepatitis, Delta
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Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China

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ClinicalTrials.gov Identifier: NCT05451082
Recruitment Status : Not yet recruiting
First Posted : July 11, 2022
Last Update Posted : July 11, 2022
Sponsor:
Information provided by (Responsible Party):
Lai Wei, Beijing Tsinghua Chang Gung Hospital

Study Description
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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.


Condition or disease
Hepatitis D

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry-based Study in Patients With Hepatitis D Virus (HDV) Infection in China
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Single Group Assignment


Outcome Measures
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Primary Outcome Measures :
  1. The incidence of death of patients infected with HDV during 5-year follow-up [ Time Frame: 5 years ]
    HDV means hepatitis D virus

  2. The incidence of liver transplantation of patients infected with HDV during 5-year follow-up [ Time Frame: 5 years ]
    HDV means hepaitis D virus

  3. The incidence of hepatocellular carcinoma of patients infected with HDV during 5-year follow-up [ Time Frame: 5 years ]
    HDV means hepaitis D virus

  4. The incidence of liver decompensation of patients infected with HDV during 5-year follow-up [ Time Frame: 5 years ]
    liver decompensation means ascites, variceal bleeding, or hepatic encephalopathy

  5. The incidence of cirrhosis of patients infected with HDV during 5-year follow-up [ Time Frame: 5 years ]
    Patients who developed cirrhosis in the absence of cirrhosis at baseline by liver biopsy or noninvasive testing


Secondary Outcome Measures :
  1. Demographic characteristics of HDV-infected individuals using baseline data [ Time Frame: 1 year ]
    Demographic characteristics: age, sex, height, weight, nationality, main residence, economic level.

  2. Epidemiological characteristics of HDV-infected individuals using baseline data [ Time Frame: 1 year ]
    Risk factors for infection/possible route of infection, HDV genotype

  3. Serum HDV RNA levels of patients infected with HDV [ Time Frame: 5 years ]
    HDV means hepaitis D virus

  4. Serum HBV DNA levels of patients infected with HDV [ Time Frame: 5 years ]
    HBV means hepaitis B virus, HDV means hepaitis D virus

  5. HBsAg concentration levels of patients infected with HDV [ Time Frame: 5 years ]
    HBsAg means Hepatitis B surface antigen，HDV means hepaitis D virus

  6. Serum alanine aminotransferase concentration levels of patients infected with HDV [ Time Frame: 5 years ]
    HDV means hepaitis D virus

  7. Serum total bilirubin concentration levels of patients infected with HDV [ Time Frame: 5 years ]
    HDV means hepaitis D virus

  8. Serum albumin levels concentration levels of patients infected with HDV [ Time Frame: 5 years ]
    HDV means hepaitis D virus

  9. Child-Pugh scores of patients infected with HDV [ Time Frame: 5 years ]
    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.

  10. The incidence of death of chronic HDV-infected patients with persistently normal ALT [ Time Frame: 5 years ]
    HDV means hepaitis D virus, ALT means alanine aminotransferase

  11. The incidence of liver transplantation of chronic HDV-infected patients with persistently normal ALT [ Time Frame: 5 years ]
    HDV means hepaitis D virus, ALT means alanine aminotransferase

  12. The incidence of hepatocellular carcinoma (HCC) of chronic HDV-infected patients with persistently normal ALT [ Time Frame: 5 years ]
    HDV means hepaitis D virus, ALT means alanine aminotransferase

  13. The incidence of liver decompensation of chronic HDV-infected patients with persistently normal ALT [ Time Frame: 5 years ]
    HDV means hepaitis D virus, ALT means alanine aminotransferase

  14. The incidence of cirrhosis of chronic HDV-infected patients with persistently normal ALT [ Time Frame: 5 years ]
    HDV means hepaitis D virus, ALT means alanine aminotransferase

  15. The proportion of patients with HDV RNA negative conversion of patients receiving antiviral therapies [ Time Frame: 5 years ]
    HDV RNA negative conversion means HDV RNA< lower limit of quantification（LLOQ）

  16. The proportion of patients with a >2lg IU/mL HDV RNA decline of patients receiving antiviral therapies [ Time Frame: 5 years ]
    The proportion of patients with a HDV RNA decrease of greater than 2log IU/mL

  17. Changes in serum HDV RNA during treatment and after discontinuation [ Time Frame: 5 years ]
    HDV means hepatitis D virus

  18. The proportion of patients with ALT normalization of patients receiving antiviral therapies [ Time Frame: 5 years ]
    ALT means alanine aminotransferase，ALT normalization means ALT <ULN

  19. Combined response rate of patients with antiviral therapy [ Time Frame: 5 years ]
    Combined response means HDV RNA <LLOQ and ALT<ULN

  20. Number of patients with abnormal laboratory values and/or adverse events that are related to antiviral treatment [ Time Frame: 5 years ]
    Number of patients with adverse events, sever adverse events, abnormal laboratory parameters, and drug combinations


Biospecimen Retention:   Samples With DNA
Whole Blood

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HDV-infected individuals with a positive HDV RNA test result
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05451082


Contacts
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Contact: Lai Wei, MD +86-10 5611 8881 weilai@mail.tsinghua.edu.cn
Contact: Feng Xue +86- 18810799293 xuef21@mails.tsinghua.edu.cn

Locations
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China, Beijing
Bejing Tsinghua Changgung Hospital
Beijing, Beijing, China, 100015
Contact: Lai Wei, MD    (+86)10 5611 8881    weilai@mail.tsinghua.edu.cn   
Contact: Feng Xue    (+86)18810799293    xuef21@mails.tsinghua.edu.cn   
Sponsors and Collaborators
Lai Wei
More Information
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Publications:

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Responsible Party: Lai Wei, Professor, Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier: NCT05451082    
Other Study ID Numbers: 22201-4-02
First Posted: July 11, 2022    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lai Wei, Beijing Tsinghua Chang Gung Hospital:
hepatitis D virus
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis D
Hepatitis
Hepatitis, Viral, Human
Infections
Liver Diseases
 Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections