Chronic Hepatitis bNCT04519359
Biomarkers Guided Stopping NAs Treatment
A study testing Stop NAs therapy in people with Chronic Hepatitis b, run by Nanfang Hospital, Southern Medical University at 5 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis b
- What is being tested?
- Stop NAs therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 5 sitesChina
- Study dates
- 6 Jul 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Hong Ma, MD, mahongmd@aliyun.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Huiying Rao, MD, rao.huiying@163.com
- Recruiting
No. 1 Hospital affiliated to Jilin University
Changchun, Jilin
Yanhang Gao, MD, gyhd0165@163.com
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality
Qing Xie, MD, xieqingrjh@163.com
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Xiaoguang Dou, MD, guang40@163.com
About this study
Official title: Novel Biomarkers Guided Stopping Nucleos(t)Ide Analogues After Long-term Virologic Suppression in CHB Patients: a Randomized Control Trial
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.
- Conditions
- Chronic Hepatitis b
- Being tested
- Stop NAs therapy
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop NAs therapyOther
Stop NAs therapy
| Study group | Role | What they receive |
|---|---|---|
| Stop Arm | Experimental | Stop NAs therapy Receives: Other: Stop NAs therapy |
| Continue Arm | No intervention | Continue NAs therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 72
Secondary outcomes (4)
Proportion of Participants With Sustained Disease Remission at Week 72 in Both Study Arms
Sustained Disease Remission is defined as HBeAg negativity, HBV DNA <2000 IU/mL and ALT normalization at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Measured: Week 72
Proportion of Participants With Clinical Relapse at Week 72 in Both Study Arms
Clinical Relapse is defined as HBV DNA >2000 IU/mL and ALT >2 ULN at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Measured: Week 72
Proportion of Participants With Virologic Relapse at Week 72 in Both Study Arms
Virologic Relapse is defined as HBV DNA >2000 IU/mL at two consecutive timepoints [at least 14 days apart] at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate.
Measured: Week 72
Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms
The analyses were summarized by 3 treatment subgroups: Stop NAs (NAs-Free), Restart NAs, and Continue NAs When participant randomized in the Stop NAs group restarted NAs therapy, that participant was considered part of the Restart NAs group from that point forward. For Restart NAs group, baseline is defined as the last available record on or prior to the restart date of NAs.
Measured: Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start6 Jul 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519359
- Sponsor's protocol ID
- STOP-01
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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. 2026 Jun;24(6):1611-1620. doi: 10.1016/j.cgh.2025.09.009. Epub 2025 Sep 13.
PubMed 40953786
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarkers Guided Stopping Nucleos(t)Ide Analogues After Long-term Virologic Suppression in CHB Patients: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04519359
- Acronym / sponsor ID
- STOP-01
- Conditions
- Chronic Hepatitis b
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stop Arm | Experimental | Other: Stop NAs therapyStop NAs therapy |
| Continue Arm | No intervention | –Continue NAs therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-65 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stop NAs therapyStop NAs therapy | Other | Stop Arm |
Primary outcome
Proportion of Participants With HBsAg Loss at Week 72 in Both Study Arms
Time frame: Week 72
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.
4 secondary outcomes
Proportion of Participants With Sustained Disease Remission at Week 72 in Both Study Arms
Time frame: Week 72
Proportion of Participants With Clinical Relapse at Week 72 in Both Study Arms
Time frame: Week 72
Proportion of Participants With Virologic Relapse at Week 72 in Both Study Arms
Time frame: Week 72
Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms
Time frame: Week 72
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Derived from this study: PubMed 40953786Fan 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. 2026 Jun;24(6):1611-1620. doi: 10.1016/j.cgh.2025.09.009. Epub 2025 Sep 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stop NAs therapy in people with Chronic Hepatitis b, run by Nanfang Hospital, Southern Medical University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Sun, MD (86-20-62787432, doctorsunjian@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With HBsAg Loss at Week 72 in Both Study Arms (time frame: Week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04519359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.