Real-world Study Optimizing Nucleotide-analogues

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.

Conditions

• Hepatitis B, Chronic

Interventions

DRUG

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

DRUG

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

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Beijing YouAn Hospital

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Xiamen Hospital of Traditional Chinese Medicine

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• LanZhou University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• The Affiliated Hospital Of Guizhou Medical University

  collaborator OTHER

• Hainan General Hospital

  collaborator OTHER

• Hebei Medical University Third Hospital

  collaborator OTHER

• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Central South University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• the Second Hospital of Nangjing

  collaborator UNKNOWN

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Qingdao Sixth People's Hospital

  collaborator UNKNOWN

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The Second Hospital of Shandong University

  collaborator OTHER

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Tianjin Second People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• The First People's Hospital of Yunnan

  collaborator OTHER

• Shulan (Hangzhou) Hospital

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• The Second Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• Huashan Hospital

  lead OTHER

Principal Investigators

• Wenghong Zhang, MD · Huashan Hospital

• Jiming Zhang, MD · Huashan Hospital

• Feng S, MD · Huashan Hospital

• Qiran Zhang, MD · Huashan Hospital

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-31

Primary Completion

2029-01-31

Completion

2029-01-31

Countries

• China

Study Locations