NCT03777969

Brief Summary

A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are enrolled. All the patients will receive original antiviral treatment for the following 10 years. Patients will be assessed at baseline and at every six months for blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death, will be collected during follow-up.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2018Dec 2028

Study Start

First participant enrolled

June 29, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

10.5 years

First QC Date

October 27, 2018

Last Update Submit

September 2, 2022

Conditions

Chronic Hepatitis b

Keywords

Chronic Hepatitis BLiver fibrosis/cirrhosisHBV-related endpoint eventsPrecise prediction model

Outcome Measures

Primary Outcomes (1)

  • HBV-related clinical endpoint events, including liver decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), HCC, liver transplantation and liver-related death

    Incidence of HBV-related clinical endpoint events during follow-ups

    1 to 10 years

Secondary Outcomes (3)

  • Predicted probability of HBV-related clinical endpoint events

    1 to 10 years

  • Predicted probability of HBV-induced fibrosis/cirrhosis regression

    1 to 10 years

  • Percentage of HBV-induced liver fibrosis/cirrhosis regression

    1 to 10 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CHB patients with liver biopsy performed at least 1 year after antiviral therapy; or CHB patients with antiviral therapy for at least 1 year content to be performed liver biopsy at enrollment.

You may qualify if:

  • No age limit;
  • Male or female;
  • Patients with liver biopsy performed at least 1 year after antiviral therapy; patients with history of clinical endpoint events (decompensated cirrhosis, hepatocellular carcinoma, liver transplantation or liver-related death) after liver biopsy;
  • Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment.

You may not qualify if:

  • Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy;
  • Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases;
  • Patients with malignant lesion on liver image;
  • Patients with other uncured malignant tumors;
  • Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases;
  • Pregnant or lactating women;
  • Patients with any other reasons not suitable for the study.
  • Group 2: Patients without history of clinical endpoint events
  • No age limit;
  • Male or female;
  • Patients with liver biopsy performed at least 1 year after antiviral therapy; or chronic hepatitis B (CHB) patients with antiviral therapy at least 1 year content to be performed liver biopsy at enrollment;
  • Patients with liver biopsy or liver stiffness or APRI before antiviral treatment;
  • Agree to be followed up regularly;
  • Signature of informed consent.
  • Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Wuxi Hisky Medical Technologies Co., Ltd.

Wuxi, Jiangsu, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Location

Hangzhou Choutu Technology Co.,Ltd.

Hangzhou, Zhejiang, China

Location

Related Publications (1)

  • Sun Y, Chen W, Chen S, Wu X, Zhang X, Zhang L, Zhao H, Xu M, Chen Y, Piao H, Li P, Li L, Jiang W, Li X, Xing H, Liu X, Zhang Y, Wang B, Zhou J, Meng T, Zhao X, Shao C, Kong Y, Zhao X, Ou X, Liu C, Jia J, You H. Regression of Liver Fibrosis in Patients on Hepatitis B Therapy Is Associated With Decreased Liver-Related Events. Clin Gastroenterol Hepatol. 2024 Mar;22(3):591-601.e3. doi: 10.1016/j.cgh.2023.11.017. Epub 2023 Nov 30.

    PMID: 38040276DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy and peripheral blood

MeSH Terms

Conditions

Hepatitis B, ChronicLiver CirrhosisFibrosis

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hong You, Doctor

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Beijing Friendship Hospital

Study Record Dates

First Submitted

October 27, 2018

First Posted

December 19, 2018

Study Start

June 29, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

September 6, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)