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NCT Number: NCT05451082

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

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.

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Key information

Conditions

Hepatitis D Digestive System Diseases Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bejing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 100015, China

Location contact

Feng Xue

CONTACT

[email protected]

(+86)18810799293

Lai Wei, MD

CONTACT

[email protected]

(+86)10 5611 8881

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Xue

CONTACT

[email protected]

+86- 18810799293

Lai Wei, MD

CONTACT

[email protected]

+86-10 5611 8881

Sponsors and collaborators

Lead sponsor

Lai Wei

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jul 11, 2022
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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