Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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