NCT05937178 Real-world Study Optimizing Nucleotide-analogues
| NCT ID | NCT05937178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huashan Hospital |
| Condition | Hepatitis B, Chronic |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 2023-01-31 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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) : A. 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 1. Age\>30 years, and have a family history of cirrhosis or HCC, TE indicates no significant fibrosis; 2. Family history of cirrhosis or HCC, and ≤30 years, TE indicates no significant fibrosis; 3. 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) : A. 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 Exclusion Criteria: * Have poor compliance; * 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
Contact & Investigator
Wenghong Zhang, MD
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT05937178 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hepatitis B, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05937178 currently recruiting?
Yes, NCT05937178 is actively recruiting participants. Contact the research team at zhangwenhong@fudan.edu.cn for enrollment information.
Where is the NCT05937178 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT05937178 clinical trial?
NCT05937178 is sponsored by Huashan Hospital. The principal investigator is Wenghong Zhang, MD at Huashan Hospital. The trial plans to enroll 20,000 participants.