Real-world Study Optimizing Nucleotide-analogues

Recruiting now

Conditions studied: Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT05937178

Run by

Huashan Hospital

People needed

20000

Starts

2023-01-31

Expected to finish

2029-01-31

Last updated by the study team

2023-07-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Age>30 years, and have a family history of cirrhosis or HCC, TE indicates no significant fibrosis;
• Family history of cirrhosis or HCC, and ≤30 years, TE indicates no significant fibrosis;
• 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

You may not qualify if…

• 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

Where it is running

• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
• the Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (enrolling)
• Huashan Hospital — Shanghai, China (enrolling)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• the Southwest Hospital of AMU — Chongqing, Chongqing Municipality, China
• First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
• Xiamen Hospital of Traditional Chinese Medicine — Xiamen, Fujian, China
• the First Hospital of Lanzhou University — Lanzhou, Gansu, China
• First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
• The Affiliated Hospital Of Guizhou Medical University — Guiyang, Guizhou, China
• The Second Affiliated Hospital of Harbin Medical University — Ha’erbin, Ha'erbin, China
• Hainan General Hospital — Haikou, Hainan, China
• the Third Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• Henan Provincial People's Hospital — Zhengzhou, Henan, China
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine — Zhengzhou, Henan, China
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China
• Tongji Hospital — Wuhan, Hubei, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• the Second Xiangya Hospital of Central South University — Changsha, Hunan, China
• Xiangya Hospital Central South University — Changsha, Hunan, China
• Jiangsu Province Hospital — Nanjing, Jiangsu, China
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China
• the Second Hospital of Nangjing — Nanjing, Jiangsu, China
• the First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• the First Bethune Hospital Of Jilin University — Changchun, Jilin, China

Full record on ClinicalTrials.gov

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