Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B

  • STATUS
    Recruiting
  • End date
    Jul 25, 2030
  • participants needed
    20000
  • sponsor
    Huashan Hospital
Updated on 30 May 2021
tenofovir
hepatitis
cirrhosis
entecavir
hepatocellular carcinoma

Summary

This is a multicenter, prospective, real-world study, recruiting patients with chronic hepatitis B under anti-viral treatment. The recruited participants will receive peginterferon alpha based regimen or nucleos(t)ide alone. The primary objective of this study is to compare the long-term outcomes (including hepatocellular carcinoma, decompensated cirrhosis, etcof different anti-viral therapies. The secondary objective of this study is to compare the serological response rates of different anti-viral therapies, evaluate the predictive value of HBV-related laboratory testings and describe the kinetics of them results during antiviral treatment. The follow-up time course of this study will be 5 years.

Description

The patients will be allocated into two cohorts based on the anti-viral treatment decided by their doctors. If they are going to take peginterferon alpha based regimen, they will be allocated in interferon cohort. If they are going to take nucleos(t)ide alone, they will be allocated in nucleos(t)ide cohort. The follow-up plan will be made by their doctors according to their conditions. No extra intervention or examination will be given in this study. The primary outcome is end-stage liver diseases including hepatocellular carcinoma and decompensated cirrhosis, and the rate of hepatocellular carcinoma and decompensated cirrhosis will be measure at 1 year2 years3 years, 4 years and 5 years from baseline. Secondary events including HBsAg loss, HBeAg conversion, fibrosis progression and fibrosis, which will be measured at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively. Results of laboratory testings will be recorded at each follow-up visit. The primary objective of this study is to compare the long-term outcomes (including hepatocellular carcinoma, decompensated cirrhosis, etcof different anti-viral therapies. The secondary objective of this study is to compare the serological response rates of different anti-viral therapies, evaluate the predictive value of HBV-related laboratory testings and describe the kinetics of them results during antiviral treatment.

Details
Condition chronic hepatitis b, Hepatitis B
Treatment Nucleos(t)ide, peginterferon alpha based regimen
Clinical Study IdentifierNCT04896255
SponsorHuashan Hospital
Last Modified on30 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female patients with age 18; subjects who are over 70 years of age must be in generally stable health conditions
There should be evidences that HBsAg has been positive for more than 6 months or HBV-related histological changes
Planned to receive or already receiving anti-viral treatment with nucleos(t)ide including Entecavir, Tenofovir, and Tenofoviralafenamide. Or planned to receive peginterferon alpha 2b, either treated or treatment-naive
Agree to participate in the study and sign the patient informed consent form

Exclusion Criteria

Currently treatment-related participating clinical trials
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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