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NCT05937178Recruiting

Real-world Study Optimizing Nucleotide-analogues

A Real-world Study of Optimizing Nucleotide-analogues-based Treatment for Chronic Hepatitis B

Source: ClinicalTrials.gov · Last updated 10 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
20000 (estimated)
First submitted
28 Jun 2023
Start date
31 Jan 2023
Primary completion date
31 Jan 2029
Lead sponsor
Huashan Hospital
Diseases
Hepatitis B
NCT number
NCT05937178

What you commit to

  • Study type: Observational
  • Planned participants: 20000
  • From 31 Jan 2023 to the primary completion date, 31 Jan 2029
  • 44 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • Have poor compliance;

Who the study is looking for

  • 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) :
  • 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) :
  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing YouAn Hospita
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BeijingChinaNot yet recruiting
Peking University First Hospital
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BeijingChinaRecruiting
Peking University People's Hospital
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BeijingChinaNot yet recruiting
The First Bethune Hospital of Jilin University
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ChangchunChinaNot yet recruiting
The Second Xiangya Hospital of Central South University
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ChangshaChinaNot yet recruiting
Xiangya Hospital Central South University
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ChangshaChinaNot yet recruiting
Sichuan Provincial People's Hospital
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ChengduChinaNot yet recruiting
West China Hospital of Sichuan University
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ChengduChinaNot yet recruiting
The Southwest hospital of AMU
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ChongqingChinaNot yet recruiting
The Second Affiliated Hospital of Chongqing Medical University
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ChongqingChinaNot yet recruiting
First Affiliated Hospital of Fujian Medical University
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FuzhouChinaNot yet recruiting
The Affiliated Hospital of Guizhou Medical University
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GuiyangChinaNot yet recruiting
The Second Affiliated Hospital of Harbin Medical University
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Ha’erbinChinaNot yet recruiting
Hainan General Hospital
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HaikouChinaNot yet recruiting
Shulan(Hangzhou) Hospital
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HangzhouChinaNot yet recruiting
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaNot yet recruiting
Anhui Provincial Hospital
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HefeiChinaNot yet recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
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JinanChinaNot yet recruiting
The Second Hospital of Shandong University
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JinanChinaNot yet recruiting
First People's Hospital of Yunnan Province
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KunmingChinaNot yet recruiting
The First Hospital of Lanzhou University
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LanzhouChinaNot yet recruiting
Third Affiliated Hospital, Sun Yat-Sen University
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MeizhouChinaNot yet recruiting
The First Affiliated Hospital of NanChang University
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NanchangChinaNot yet recruiting
Jiangsu Province Hospital
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NanjingChinaNot yet recruiting
the Second Hospital of Nangjing
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NanjingChinaNot yet recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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NanjingChinaNot yet recruiting
First Affiliated Hospital of Guangxi Medical University
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NanningChinaNot yet recruiting
No. 6 People's Hospital of Qingdao
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QingdaoChinaNot yet recruiting
Ruijin hospital
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ShanghaiChinaNot yet recruiting
Huashan Hospital
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ShanghaiChinaRecruiting
Shengjing Hospital Of China Medical University
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ShenyangChinaNot yet recruiting
The Third Hospital of Hebei Medical University
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ShijiazhuangChinaNot yet recruiting
First Hospital of Shanxi Medical University
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TaiyuanChinaNot yet recruiting
Tianjin Second People's Hospital
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TianjinChinaNot yet recruiting
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
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ÜrümqiChinaNot yet recruiting
Tongji Hospital
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WuhanChinaNot yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaNot yet recruiting
Renmin Hospital of Wuhan University
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WuhanChinaNot yet recruiting
Xiamen Hospital of Traditional Chinese Medicine
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XiamenChinaNot yet recruiting
Tangdu Hospital, The Fourth Military Medical University
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Xi’anChinaNot yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaNot yet recruiting
The affiliated hospital of xuzhou medical university
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XuzhouChinaRecruiting
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
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ZhengzhouChinaNot yet recruiting
Henan Provincial People's Hospital
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ZhengzhouChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.