Chronic Hepatitis bPhase 3NCT07588009

Phase IIIB Extension Clinical Trial of Efficacy and Safety of GST-HG141 (Nairevir) Combined With NAs in Chronic Hepatitis B

A Phase 3 study testing GST-HG141 in people with Chronic Hepatitis b, run by Fujian Akeylink Biotechnology Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

This is a multicenter, single-arm, open-label, phase IIIb extension clinical trial designed to evaluate the long-term safety and tolerability of GST-HG141 (nerlecovir, 50 mg BID) in combination with nucleos(t)ide analogues (NAs) in patients with chronic hepatitis B (CHB) who completed 48 weeks of treatment in the… Read more about this study

Who is it for?: Ages 18 to 71 years
Conditions the study is for: Chronic Hepatitis b
What is being tested?: GST-HG141
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 576 participants
Where: No sites listed yet
Study dates: 26 Jun 2026to 1 Mar 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 71 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants who received the study treatment of the phase III clinical trial of GST-HG141 (GST-HG141-III-01) in accordance with the protocol requirements (participants without early withdrawal and with overall medication compliance ≥ 80%), and had ALT ≤ 5×ULN;
Participants were willing to participate in the study and were judged by the investigator to be suitable for long-term treatment with GST-HG141 combined with NAs;
Male participants with female partners of childbearing potential or female participants of childbearing potential voluntarily adopted effective contraceptive measures from screening to 28 days after study withdrawal ;
Signed the informed consent form prior to the trial and were able to complete the study in accordance with the requirements of the trial protocol.

Who cannot join

Presence of severe systemic infection requiring treatment;
Suffering from clinically significant acute or chronic liver diseases not caused by HBV infection;
Participants with a history of liver cirrhosis; or currently diagnosed or suspected decompensated liver cirrhosis, including but not limited to hepatic encephalopathy, hepatorenal syndrome, esophagogastric variceal bleeding, splenomegaly, ascites, etc.; or participants with significant progression of liver fibrosis;
Primary liver cancer; suspected malignant space-occupying liver lesions suggested by imaging examination; combined with other malignant tumors (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix);
Impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs as judged by the investigator;
Combined with severe diseases of the circulatory, respiratory, urinary, hematological, metabolic, immune, psychiatric, neurological, renal and other systems, and judged by the investigator to be ineligible for continued participation in the study;

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Participants with major trauma or major surgery within 3 months prior to screening; or those planning to undergo surgery during the study period;
Laboratory test abnormalities:
Platelet count < 100×10^9/L;
White blood cell count < 3.0×10^9/L;
Absolute neutrophil count < 1.3×10^9/L;
Serum total bilirubin > 2×ULN;
Albumin < 35 g/L;
Estimated glomerular filtration rate (eGFR) ≤ 60 ml·min-¹·(1.73m²)-¹ ;
International Normalized Ratio (INR) of prothrombin time > 1.5;
Lactating females or participants with a positive pregnancy test;
Participants with any other conditions deemed inappropriate for participation in this trial by the investigator.

About this study

Official title: A Single-Arm, Open-Label, Multicenter Phase IIIB Extension Clinical Trial to Evaluate the Efficacy and Safety of GST-HG141 (Nairecovir) in Combination With Nucleos(t)Ide Analogs (NAs) in Patients With Chronic Hepatitis B

A maximum of 578 eligible participants will be enrolled at 64 centers, including those who completed the preceding study, had ALT ≤5× upper limit of normal (ULN), and had no severe comorbidities (e.g., decompensated cirrhosis, other viral infections, or malignant tumors)

Conditions: Chronic Hepatitis b
Being tested: GST-HG141
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.

GST-HG141Drug
GST-HG141 50 mg BID + NAs

Study groups in NCT07588009
Study group	Role	What they receive
GST-HG141	Experimental	GST-HG141+NAs Receives: Drug: GST-HG141

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the safety of GST-HG141 combined with NAs treatment
Treatment-emergent AE incidence rate
Measured: up to 52 weeks

Secondary outcomes (9)

The percentage of participants in the experimental group of Study GST-HG141-III-01 with HBV DNA < 20 IU/mL after completing this study and receiving 48 weeks of GST-HG141 combined with NAs treatment.
Measured: up to 48 weeks
Among participants of Study GST-HG141-III-01 who had HBV DNA ≥ 20 IU/mL after completing double-blind treatment, the percentage of participants with serum HBV DNA < 20 IU/mL following 48 weeks of treatment in this study.
Measured: up to 48 weeks
The percentage of participants with serum HBV DNA < 20 IU/mL at each visit time point.
Measured: up to 48 weeks
The percentage of participants with serum HBV DNA < 10 IU/mL at each visit time point.
Measured: up to 48 weeks
Changes from baseline in quantitative serum HBV DNA levels at each visit time point.
Measured: up to 48 weeks
Time to achieve serum HBV DNA < 20 IU/mL in each group.
Measured: up to 48 weeks
The percentage of participants with serum HBsAg seroclearance at each visit time point.
Measured: up to 48 weeks
Changes from baseline in quantitative hepatitis B surface antigen (HBsAg) levels at each visit time point.
Measured: up to 48 weeks
Changes from baseline in quantitative serum hepatitis B virus pregenomic RNA (HBV pgRNA) levels at each visit time point.
Measured: up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 20261 Mar 2028

First posted14 May 2026
Study start26 Jun 2026 (estimated)
Primary completion11 Jan 2028 (estimated)
Study completion1 Mar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Hepatitis bStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 576 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07588009
Sponsor's protocol ID: GST-HG141-III-EX
Status last verified: May 2026
First submitted: 23 Apr 2026
Last updated: 14 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Chronic Hepatitis b trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Arm, Open-Label, Multicenter Phase IIIB Extension Clinical Trial to Evaluate the Efficacy and Safety of GST-HG141 (Nairecovir) in Combination With Nucleos(t)Ide Analogs (NAs) in Patients With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT07588009
Acronym / sponsor ID: GST-HG141-III-EX
Conditions: Chronic Hepatitis b
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 576 participants (estimated)
Lead sponsor: Fujian Akeylink Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 26 Jun 2026 (estimated)
Primary completion: 11 Jan 2028 (estimated)
Study completion: 1 Mar 2028 (estimated)
First posted: 14 May 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GST-HG141	Experimental	Drug: GST-HG141GST-HG141+NAs

Who may qualify

Ages: 18 to 71 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participants who received the study treatment of the phase III clinical trial of GST-HG141 (GST-HG141-III-01) in accordance with the protocol requirements (participants without early withdrawal and with overall medication compliance ≥ 80%), and had ALT ≤ 5×ULN;
Participants were willing to participate in the study and were judged by the investigator to be suitable for long-term treatment with GST-HG141 combined with NAs;
Male participants with female partners of childbearing potential or female participants of childbearing potential voluntarily adopted effective contraceptive measures from screening to 28 days after study withdrawal ;
Signed the informed consent form prior to the trial and were able to complete the study in accordance with the requirements of the trial protocol.

Key exclusion criteria (17 listed)

Presence of severe systemic infection requiring treatment;
Suffering from clinically significant acute or chronic liver diseases not caused by HBV infection;
Participants with a history of liver cirrhosis; or currently diagnosed or suspected decompensated liver cirrhosis, including but not limited to hepatic encephalopathy, hepatorenal syndrome, esophagogastric variceal bleeding, splenomegaly, ascites, etc.; or participants with significant progression of liver fibrosis;
Primary liver cancer; suspected malignant space-occupying liver lesions suggested by imaging examination; combined with other malignant tumors (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix);
Impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs as judged by the investigator;

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
GST-HG141GST-HG141 50 mg BID + NAs	Drug	GST-HG141

Primary outcome

To evaluate the safety of GST-HG141 combined with NAs treatment
Time frame: up to 52 weeks
Treatment-emergent AE incidence rate

9 secondary outcomes

The percentage of participants in the experimental group of Study GST-HG141-III-01 with HBV DNA < 20 IU/mL after completing this study and receiving 48 weeks of GST-HG141 combined with NAs treatment.
Time frame: up to 48 weeks
Among participants of Study GST-HG141-III-01 who had HBV DNA ≥ 20 IU/mL after completing double-blind treatment, the percentage of participants with serum HBV DNA < 20 IU/mL following 48 weeks of treatment in this study.
Time frame: up to 48 weeks
The percentage of participants with serum HBV DNA < 20 IU/mL at each visit time point.
Time frame: up to 48 weeks
The percentage of participants with serum HBV DNA < 10 IU/mL at each visit time point.
Time frame: up to 48 weeks
Changes from baseline in quantitative serum HBV DNA levels at each visit time point.
Time frame: up to 48 weeks
Time to achieve serum HBV DNA < 20 IU/mL in each group.
Time frame: up to 48 weeks
The percentage of participants with serum HBsAg seroclearance at each visit time point.
Time frame: up to 48 weeks
Changes from baseline in quantitative hepatitis B surface antigen (HBsAg) levels at each visit time point.
Time frame: up to 48 weeks
Changes from baseline in quantitative serum hepatitis B virus pregenomic RNA (HBV pgRNA) levels at each visit time point.
Time frame: up to 48 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.

Related trials for Chronic Hepatitis b

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GST-HG141 in people with Chronic Hepatitis b, run by Fujian Akeylink Biotechnology Co., Ltd..

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 4 inclusion and 17 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: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety of GST-HG141 combined with NAs treatment (time frame: up to 52 weeks). 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 NCT07588009.

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 14 May 2026.