Biomarkers Guided Stopping NAs Treatment
Novel Biomarkers Guided Stopping Nucleos(t)Ide Analogues After Long-term Virologic Suppression in CHB Patients: a Randomized Control Trial
1 other identifier
interventional
195
1 country
5
Brief Summary
The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss in subjects who stop nucles(t)ide analogues (NAs) (Stop arm) compared to subjects who continue (Continue arm) Only subjects who already are on treatment with ETV, TDF or TAF monotherapy, and have achieved sustained virologic suppression (\<20 IU/mL), HBeAg negativity, normal ALT for more than 1 year (pretreatment HBeAg + pts) or 3 years (pretreatment HBeAg - pts), plus qHBsAg \<200 IU/mL, and HBV RNA or HBcrAg negativity will be included in this study. One treatment arm will stop the NAs therapy while the other treatment arm will continue the NAs therapy. Participants in the Stop arm will be monitored very closely with special focus on clinical relapse. If any participant in the Stop NAs arm exceeds one or more predefined limits for such flares or relapses, NAs treatment will be reinstituted.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2020
CompletedFirst Submitted
Initial submission to the registry
August 17, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedAugust 19, 2020
August 1, 2020
3 years
August 17, 2020
August 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of Participants With HBsAg Loss at Week 72 in Both Study Arms
HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Week 72
Secondary Outcomes (4)
Proportion of Participants With Sustained Disease Remission at Week 72 in Both Study Arms
Week 72
Proportion of Participants With Clinical Relapse at Week 72 in Both Study Arms
Week 72
Proportion of Participants With Virologic Relapse at Week 72 in Both Study Arms
Week 72
Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms
Week 72
Study Arms (2)
Stop Arm
EXPERIMENTALStop NAs therapy
Continue Arm
NO INTERVENTIONContinue NAs therapy
Interventions
Eligibility Criteria
You may qualify if:
- years of old, male or female
- 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
You may not qualify if:
- Experience of IFN treatment within 1 year prior to screening
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Related Publications (1)
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 NAs 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.
PMID: 40953786DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2020
First Posted
August 19, 2020
Study Start
July 6, 2020
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
August 19, 2020
Record last verified: 2020-08