Real-world Study Optimizing Nucleotide-analogues

Condition(s) studied

Investigational drug(s) / intervention(s)

ETV/TAF/TDF/TMF/IFN: peginterferon alpha or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study

ETV/TAF/TDF/TMF: peginterferon alpha or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study

Study summary

The goal of this multicenter, observational, prospective study is to observe and compare different anti-viral treatment strategies in a real-world cohort of patients with CHB managed in routine clinical settings in China. The main questions it aims to answer are:

1. To evaluate the benefits of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who are recommended in the updated Chinese Guideline 2022, but not recommended in the Chinese Guideline 2019.
2. To evaluate the Chinese Guideline recommends initiation of treatment, but at least one foreign authoritative guideline (eg. AASLD, EASL) does not recommend the benefit of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who initiate treatment.
3. To compare the treatment effect of different alternatives with patients who have partial response after treatment with first-line nucleos(t)ide analogues.

Eligibility

Primary outcome measure(s)

• The proportion of patients with HBV DNA <20 IU/ml — Week 48
  The primary efficacy endpoint was the proportion of patients with HBV DNA \<20 IU/ml at each follow-up time point, as determined by high-sensitivity PCR
• The proportion of patients with HBV DNA <20 IU/ml — Week 96
  The primary efficacy endpoint was the proportion of patients with HBV DNA \<20 IU/ml at each follow-up time point, as determined by high-sensitivity PCR
• The proportion of patients with HBV DNA <20 IU/ml — Week 144
  The primary efficacy endpoint was the proportion of patients with HBV DNA \<20 IU/ml at each follow-up time point, as determined by high-sensitivity PCR
• Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) — Baseline
  Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at each follow-up time point
• Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) — Week 48
  Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at each follow-up time point
• Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) — Week 96
  Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at each follow-up time point
• Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) — Week 144
  Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at each follow-up time point

Trial sites (44)

+ 4 more sites — see the full list on the official registry below.

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