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AzTrials

Hepatitis DNCT05451082

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

An observational study of Hepatitis D, run by Lai Wei at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis D
How many people
1,000 participants
Where
1 siteChina
Study dates
Jul 2022to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HDV-infected individuals with a positive HDV RNA test result

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lai Wei, MD contact

+86-10 5611 8881

weilai@mail.tsinghua.edu.cn

Feng Xue contact

+86- 18810799293

xuef21@mails.tsinghua.edu.cn

China1 site

  • Bejing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 100015

    Lai Wei, MD, (+86)10 5611 8881, weilai@mail.tsinghua.edu.cn

    Feng Xue, (+86)18810799293, xuef21@mails.tsinghua.edu.cn

Other trials in China

About this study

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.

Conditions
Hepatitis D
Keywords
hepatitis D virus
Medical subject headings
Hepatitis D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05451082
Study groupRoleWhat they receive
Single Group AssignmentNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of death of patients infected with HDV during 5-year follow-up

    HDV means hepatitis D virus

    Measured: 5 years

  2. The incidence of liver transplantation of patients infected with HDV during 5-year follow-up

    HDV means hepaitis D virus

    Measured: 5 years

  3. The incidence of hepatocellular carcinoma of patients infected with HDV during 5-year follow-up

    HDV means hepaitis D virus

    Measured: 5 years

  4. The incidence of liver decompensation of patients infected with HDV during 5-year follow-up

    liver decompensation means ascites, variceal bleeding, or hepatic encephalopathy

    Measured: 5 years

  5. 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

    Measured: 5 years

Secondary outcomes (20)

  1. Demographic characteristics of HDV-infected individuals using baseline data

    Demographic characteristics: age, sex, height, weight, nationality, main residence, economic level.

    Measured: 1 year

  2. Epidemiological characteristics of HDV-infected individuals using baseline data

    Risk factors for infection/possible route of infection, HDV genotype

    Measured: 1 year

  3. Serum HDV RNA levels of patients infected with HDV

    HDV means hepaitis D virus

    Measured: 5 years

  4. Serum HBV DNA levels of patients infected with HDV

    HBV means hepaitis B virus, HDV means hepaitis D virus

    Measured: 5 years

  5. HBsAg concentration levels of patients infected with HDV

    HBsAg means Hepatitis B surface antigen，HDV means hepaitis D virus

    Measured: 5 years

  6. Serum alanine aminotransferase concentration levels of patients infected with HDV

    HDV means hepaitis D virus

    Measured: 5 years

  7. Serum total bilirubin concentration levels of patients infected with HDV

    HDV means hepaitis D virus

    Measured: 5 years

  8. Serum albumin levels concentration levels of patients infected with HDV

    HDV means hepaitis D virus

    Measured: 5 years

  9. 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.

    Measured: 5 years

  10. The incidence of death of chronic HDV-infected patients with persistently normal ALT

    HDV means hepaitis D virus, ALT means alanine aminotransferase

    Measured: 5 years

  11. The incidence of liver transplantation of chronic HDV-infected patients with persistently normal ALT

    HDV means hepaitis D virus, ALT means alanine aminotransferase

    Measured: 5 years

  12. The incidence of hepatocellular carcinoma (HCC) of chronic HDV-infected patients with persistently normal ALT

    HDV means hepaitis D virus, ALT means alanine aminotransferase

    Measured: 5 years

  13. The incidence of liver decompensation of chronic HDV-infected patients with persistently normal ALT

    HDV means hepaitis D virus, ALT means alanine aminotransferase

    Measured: 5 years

  14. The incidence of cirrhosis of chronic HDV-infected patients with persistently normal ALT

    HDV means hepaitis D virus, ALT means alanine aminotransferase

    Measured: 5 years

  15. 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）

    Measured: 5 years

  16. 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

    Measured: 5 years

  17. Changes in serum HDV RNA during treatment and after discontinuation

    HDV means hepatitis D virus

    Measured: 5 years

  18. The proportion of patients with ALT normalization of patients receiving antiviral therapies

    ALT means alanine aminotransferase，ALT normalization means ALT <ULN

    Measured: 5 years

  19. Combined response rate of patients with antiviral therapy

    Combined response means HDV RNA <LLOQ and ALT<ULN

    Measured: 5 years

  20. 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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study startJul 2022 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05451082
Sponsor's protocol ID
22201-4-02
Status last verified
Jul 2022
First submitted
26 Jun 2022
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 34331781

  • 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.

    PubMed 33484770

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis D, run by Lai Wei at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lai Wei, MD (+86-10 5611 8881, weilai@mail.tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of death of patients infected with HDV during 5-year follow-up (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05451082, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.

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