Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
195 participants
INTERVENTIONAL
2020-07-06
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Stop Arm
Stop NAs therapy
Stop NAs therapy
Stop NAs therapy
Continue Arm
Continue NAs therapy
No interventions assigned to this group
Interventions
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Stop NAs therapy
Stop NAs therapy
Eligibility Criteria
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Inclusion Criteria
* Chronic hepatitis B patients
* Received continuous ETV, TDF or TAF therapy for at least 1 year prior to screening and at screening
* For patients with Hepatitis B e Antigen (HBeAg)-positive at the beginning of NAs therapy, documented hepatitis B virus \<20 IU/mL, HBeAg seroconversion and ALT normalization for at least 1 year prior to screening and at screening
* For patients with HBeAg-negative at the beginning of NAs therapy, documented hepatitis B virus \<20 IU/mL, and ALT normalization for at least 3 year prior to screening and at screening
* \<= 9 kPa on Fibroscan assessment
* qHBsAg \<200 IU/mL within 24 weeks prior to screening
* HBV RNA or HBcrAg negativity within 24 weeks prior to screening
Exclusion Criteria
* Known cirrhosis
* History of decompensated liver disease
* History of clinical hepatic decompensation in the judgement of the investigator
* Evidence of hepatocellular carcinoma
* Serological evidence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D infection
* Known hypersensitivity to TDF, its metabolites, or formulation excipients
* History of malignant disease
* Lactating females
* Females wishing to became pregnant during the duration of the study
* Subjects participating in another clinical trial
18 Years
65 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
No. 1 Hospital affiliated to Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Fan R, Deng R, Xie Q, Wang F, Liang X, Ma H, Rao H, Gao Y, Zhong C, Guo Q, Shen S, Xu Y, Lu X, Gao H, Bai H, Dou X, Sun J. Novel HBV Biomarkers-Guided NA Withdrawal Strategy Promotes HBsAg Clearance in Asian CHB Patients: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Sep 13:S1542-3565(25)00799-2. doi: 10.1016/j.cgh.2025.09.009. Online ahead of print.
Other Identifiers
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STOP-01
Identifier Type: -
Identifier Source: org_study_id
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