Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT05937178

Real-world Study Optimizing Nucleotide-analogues

Led by Huashan Hospital · Updated on 2023-07-10

20000

Participants Needed

44

Research Sites

313 weeks

Total Duration

On this page

Sponsors

H

Huashan Hospital

Lead Sponsor

T

The First Affiliated Hospital of Anhui Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Real-world Study Optimizing Nucleotide-analogues

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chronic hepatitis B defined as positive hepatitis B surface antigen for at least 6 months, or HBV-related liver changes within 1 year if HBsAg positive less than 6 months
  • Age between 18 and 80 years
  • Ability and willingness to read and sign informed consent
  • Meet conditions for one of these groups: Group A: Treatment-naive meeting 2022 Chinese Guideline recommendations but not 2019 Guideline Group B: Treatment-naive meeting both 2019 and 2022 Chinese Guidelines but not AASLD/EASL guidelines Group C: Treatment-experienced with partial response after at least 48 weeks of first-line nucleos(t)ide analogue monotherapy
Not Eligible

You will not qualify if you...

  • Poor treatment compliance
  • Use of prohibited concomitant drugs or known allergic reactions to study drugs or their ingredients
  • Any clinical symptoms or previous treatments that make participation unsuitable or prevent compliance

AI-Screening

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Trial Site Locations

Total: 44 locations

1

Anhui Provincial Hospital

Hefei, Anhui, China, 230000

Not Yet Recruiting

2

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230000

Not Yet Recruiting

3

Beijing YouAn Hospita

Beijing, Beijing Municipality, China, 100000

Not Yet Recruiting

4

Peking University First Hospital

Beijing, Beijing Municipality, China, 100000

Actively Recruiting

5

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100000

Not Yet Recruiting

6

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400000

Not Yet Recruiting

7

the Southwest Hospital of AMU

Chongqing, Chongqing Municipality, China, 400000

Not Yet Recruiting

8

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350000

Not Yet Recruiting

9

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, Fujian, China, 361000

Not Yet Recruiting

10

the First Hospital of Lanzhou University

Lanzhou, Gansu, China, 730000

Not Yet Recruiting

11

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China, 530000

Not Yet Recruiting

12

The Affiliated Hospital Of Guizhou Medical University

Guiyang, Guizhou, China, 55000

Not Yet Recruiting

13

The Second Affiliated Hospital of Harbin Medical University

Ha’erbin, Ha'erbin, China, 150000

Not Yet Recruiting

14

Hainan General Hospital

Haikou, Hainan, China, 570100

Not Yet Recruiting

15

the Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China, 050000

Not Yet Recruiting

16

Henan Provincial People's Hospital

Zhengzhou, Henan, China, 450000

Not Yet Recruiting

17

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China, 450000

Not Yet Recruiting

18

Renmin Hospital of Wuhan University

Wuhan, Hubei, China, 430000

Not Yet Recruiting

19

Tongji Hospital

Wuhan, Hubei, China, 430000

Not Yet Recruiting

20

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

Wuhan, Hubei, China, 430000

Not Yet Recruiting

21

the Second Xiangya Hospital of Central South University

Changsha, Hunan, China, 430100

Not Yet Recruiting

22

Xiangya Hospital Central South University

Changsha, Hunan, China, 430100

Not Yet Recruiting

23

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210000

Not Yet Recruiting

24

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China, 210000

Not Yet Recruiting

25

the Second Hospital of Nangjing

Nanjing, Jiangsu, China, 210000

Not Yet Recruiting

26

the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Actively Recruiting

27

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330000

Not Yet Recruiting

28

the First Bethune Hospital Of Jilin University

Changchun, Jilin, China, 130000

Not Yet Recruiting

29

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110000

Not Yet Recruiting

30

Tangdu Hospital, The Fourth Military Medical University

Xi'an, Shaanxi, China, 710000

Not Yet Recruiting

31

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710000

Not Yet Recruiting

32

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China, 250000

Not Yet Recruiting

33

The Second Hospital of Shandong University

Jinan, Shandong, China, 250000

Not Yet Recruiting

34

No. 6 People's Hospital of Qingdao

Qingdao, Shandong, China, 266000

Not Yet Recruiting

35

Ruijin Hospital

Shanghai, Shanghai Municipality, China, 200000

Not Yet Recruiting

36

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China, 030000

Not Yet Recruiting

37

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China, 610000

Not Yet Recruiting

38

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 610000

Not Yet Recruiting

39

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China, 300000

Not Yet Recruiting

40

Third Affiliated Hospital, Sun Yat-Sen University

Meizhou, Xiamen, China, 514000

Not Yet Recruiting

41

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Ürümqi, Xinjiang Uygur Autonomous Region, China, 830000

Not Yet Recruiting

42

First People's Hospital of Yunnan Province

Kunming, Yunnan, China, 650000

Not Yet Recruiting

43

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, China, 310000

Not Yet Recruiting

44

Huashan Hospital

Shanghai, China, 200040

Actively Recruiting

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Research Team

W

Wenghong Zhang, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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