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
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing YouAn Hospita Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Not yet recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| The Southwest hospital of AMU Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
| First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Not yet recruiting |
| The Second Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Ha’erbin | China | Not yet recruiting |
| Hainan General Hospital Coordinator of this site? Confirm its status | Haikou | China | Not yet recruiting |
| Shulan(Hangzhou) Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| The Second Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| First People's Hospital of Yunnan Province Coordinator of this site? Confirm its status | Kunming | China | Not yet recruiting |
| The First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Not yet recruiting |
| Third Affiliated Hospital, Sun Yat-Sen University Coordinator of this site? Confirm its status | Meizhou | China | Not yet recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Not yet recruiting |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| the Second Hospital of Nangjing Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Not yet recruiting |
| No. 6 People's Hospital of Qingdao Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Huashan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| The Third Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Not yet recruiting |
| First Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Not yet recruiting |
| Tianjin Second People's Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Ürümqi | China | Not yet recruiting |
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Xiamen Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Xiamen | China | Not yet recruiting |
| Tangdu Hospital, The Fourth Military Medical University Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.