NCT03366571

Brief Summary

Patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research will receive another 7-years anti-viral therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. CT or MRI and endoscopy will be performed at baseline and 7 years. At the end of the study, the cumulative rate of clinical hepatic hard endpoint will be calculated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

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 Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

7.9 years

First QC Date

July 29, 2016

Last Update Submit

April 9, 2021

Conditions

Chronic Hepatitis B

Keywords

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Cumulative rate of liver decompensation and/or hepatic carcinoma and/or liver related death

    Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy,Gastrointestinal hemorrhage)，and/or hepatocellular carcinoma， and/or liver related death after 10 years of antiviral treatment

    10 years

Secondary Outcomes (8)

  • HBV-DNA undetectable rate

    10 years

  • Decrease of transient elastography

    10 years

  • HBeAg seroconversion rate

    10 years

  • HBsAg seroconversion rate

    10 years

  • Decrease of Child-Pugh score

    10 years

  • +3 more secondary outcomes

Study Arms (2)

Anti-viral therapy group

Subjects who have completed the 3 years research "Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis"

Drug: Nucleos(t)ide Analogues

Non anti-viral therapy group

History study from literature

Interventions

Nucleos(t)ide AnaloguesDRUG

Entecavir 0.5mg daily, Lamivudine100mg qd daily, Adefovir Dipivoxil 10mg daily, telbivudine 600mg qd daily, their combination therapy, tenofovir 300mg qd daily.

Also known as: Baraclude , et al
Anti-viral therapy group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The HBV-related chronic hepatitis /cirrhosis patients who have completed 3 years follow-up of the past Beijing Science and Technology Commission Research.

You may qualify if:

  • Patients who have participated in the research funded by Beijing science and Technology Commission and have completed 156 weeks follow-up.
  • Patients comply with the requirements of the trail voluntarily
  • Written informed consent

You may not qualify if:

  • Pregnant woman or patient with severe disease
  • Patients with poor adherence to the study
  • Patients not suitable for the study evaluated by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Ditan Hospital

Beijing, Beijing Municipality, China

Location

Beijing YouAn Hospital

Beijing, Beijing Municipality, China

Location

Peking University People's Hopsital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.

    PMID: 33460002DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma and DNA.

MeSH Terms

Conditions

Hepatitis B, ChronicLiver Cirrhosis

Interventions

entecavir

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dong J Jia, Doctor

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Liver Research Center

Study Record Dates

First Submitted

July 29, 2016

First Posted

December 8, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

April 14, 2021

Record last verified: 2021-04

Locations

CN(4)