Clinical Trials in China / NCT05937178
Recruiting
Observational
Real-world Study Optimizing Nucleotide-analogues
NCT05937178 · tracked via the Priya Life Science China tracker
Condition(s) studied
Hepatitis B, Chronic
Investigational drug(s) / intervention(s)
ETV/TAF/TDF/TMF/IFNETV/TAF/TDF/TMF
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
Inclusion Criteria:
* CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months.
* Age between 18-80 years.
* Patient who reads and signs informed consent.
* Meet any conditions of the group listed below
Group A-naïve and meeting the conditions that are recommended to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline (observe-plan to treat or control-plan to follow-up) :
A. HBV DNA positive, ALT is continuously upper limit of normal (male 30 U/L, female 19 U/L) B. HBeAg positive, HBV DNA≤2×10\^7 IU/ml; HBeAg negative, HBV DNA≥2×10\^3 IU/ml C. Meet any of the conditions listed below
1. Age\>30 years, and have a family history of cirrhosis or HCC, TE indicates no significant fibrosis;
2. Family history of cirrhosis or HCC, and ≤30 years, TE indicates no significant fibrosis;
3. TE indicates significant fibrosis, and ≤30 years, without family history of cirrhosis or HCC
Group B-naïve and meeting the conditions that are recommended to initiate treatment in both 2019 and 2022 Chinese Guidelines, but not in EASL or AASLD guideline (observe-plan to treat or control-plan to follow-up) :
A. Without cirrhosis, HBV DNA≤2000 IU/ml, ALT\>1 ULN； B. Without cirrhosis, HBV DNA\>2000 IU/ml, 1 ULN\<ALT≤2 ULN； C. Without cirrhosis, normal ALT, \>30 years, have a family history of cirrhosis or HCC, or TE indicates significant fibrosis; D. Without cirrhosis, HBV DNA 20-2000 IU/ml Group C-experienced and partial response (1. switch another first-line NA; 2. add-on another first-line NA; 3. switch another first-line NA and add-on peginterferon alpha; 4. continue the original plan) Treatment experienced patient who has received a first-line nucleos(t)ide analogue(NA) monotherapy for at least 48 weeks, i.e., entecavir, tenofovir disoproxil or tenofovir alafenamide, tenofovir amibufenamide, and has partial response. They plan to continue or change the therapy
Exclusion Criteria:
* Have poor compliance;
* Received contraindicated concomitant drugs (subjects receiving prohibited drugs will need at least 30 days of washing out period) and known hypersensitivity reactions to the study drug, metabolites, or formulated excipients;
* Any other clinical symptoms or previous treatment that the investigator considers that the individual subject is not suitable for this study or cannot comply with the administration requirements
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | Not Yet Recruiting |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | Not Yet Recruiting |
| Beijing YouAn Hospita | Beijing | Beijing Municipality | Not Yet Recruiting |
| Peking University First Hospital | Beijing | Beijing Municipality | Recruiting |
| Peking University People's Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | Not Yet Recruiting |
| the Southwest Hospital of AMU | Chongqing | Chongqing Municipality | Not Yet Recruiting |
| First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | Not Yet Recruiting |
| Xiamen Hospital of Traditional Chinese Medicine | Xiamen | Fujian | Not Yet Recruiting |
| the First Hospital of Lanzhou University | Lanzhou | Gansu | Not Yet Recruiting |
| First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | Not Yet Recruiting |
| The Affiliated Hospital Of Guizhou Medical University | Guiyang | Guizhou | Not Yet Recruiting |
| The Second Affiliated Hospital of Harbin Medical University | Ha’erbin | Ha'erbin | Not Yet Recruiting |
| Hainan General Hospital | Haikou | Hainan | Not Yet Recruiting |
| the Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | Not Yet Recruiting |
| Henan Provincial People's Hospital | Zhengzhou | Henan | Not Yet Recruiting |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | Zhengzhou | Henan | Not Yet Recruiting |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | Not Yet Recruiting |
| Tongji Hospital | Wuhan | Hubei | Not Yet Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Not Yet Recruiting |
| the Second Xiangya Hospital of Central South University | Changsha | Hunan | Not Yet Recruiting |
| Xiangya Hospital Central South University | Changsha | Hunan | Not Yet Recruiting |
| Jiangsu Province Hospital | Nanjing | Jiangsu | Not Yet Recruiting |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | Not Yet Recruiting |
| the Second Hospital of Nangjing | Nanjing | Jiangsu | Not Yet Recruiting |
| the Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | Recruiting |
| the First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | Not Yet Recruiting |
| the First Bethune Hospital Of Jilin University | Changchun | Jilin | Not Yet Recruiting |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | Not Yet Recruiting |
| Tangdu Hospital, The Fourth Military Medical University | Xi'an | Shaanxi | Not Yet Recruiting |
| the First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | Not Yet Recruiting |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | Not Yet Recruiting |
| The Second Hospital of Shandong University | Jinan | Shandong | Not Yet Recruiting |
| No. 6 People's Hospital of Qingdao | Qingdao | Shandong | Not Yet Recruiting |
| Ruijin Hospital | Shanghai | Shanghai Municipality | Not Yet Recruiting |
| First Hospital of Shanxi Medical University | Taiyuan | Shanxi | Not Yet Recruiting |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | Not Yet Recruiting |
| West China Hospital of Sichuan University | Chengdu | Sichuan | Not Yet Recruiting |
| Tianjin Second People's Hospital | Tianjin | Tianjin Municipality | Not Yet Recruiting |
| Third Affiliated Hospital, Sun Yat-Sen University | Meizhou | Xiamen | Not Yet Recruiting |
+ 4 more sites — see the full list on the official registry below.
More Huashan Hospital trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05937178 on ClinicalTrials.gov ↗ ← All trials in China