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Not yet recruitingNCT07588009Updated May 14, 2026

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

A Phase 3 interventional study of GST-HG141 in Chronic Hepatitis b, sponsored by Fujian Akeylink Biotechnology Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 71 Years. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Fujian Akeylink Biotechnology Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
576
Allocation
Not applicable
Ages
18 Years to 71 Years
Sex
All
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Study 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 phase III study (GST-HG141-III-01), did not discontinue prematurely, had an overall medication compliance rate of ≥80%, and were willing to continue treatment.

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)

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Conditions studied

  • Chronic Hepatitis b

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03

In context

Hepatitis B, Chronic

942 studies on the registry are indexed under Hepatitis B, Chronic; 145 are open to participants now.

This study's planned enrollment of 576 is above the median of 100 across 683 interventional studies indexed under Hepatitis B, Chronic.

Browse Hepatitis B, Chronic studies →

Lead sponsor

Fujian Akeylink Biotechnology Co., Ltd. is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 71 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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;
  2. 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;
  3. 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 ;
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. Presence of severe systemic infection requiring treatment;
  2. Suffering from clinically significant acute or chronic liver diseases not caused by HBV infection;
  3. 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;
  4. 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);
  5. Impaired gastrointestinal function or gastrointestinal diseases that may affect the absorption of oral drugs as judged by the investigator;
  6. 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;
  7. Participants with major trauma or major surgery within 3 months prior to screening; or those planning to undergo surgery during the study period;
  8. Laboratory test abnormalities:

    1. Platelet count \< 100×10\^9/L;
    2. White blood cell count \< 3.0×10\^9/L;
    3. Absolute neutrophil count \< 1.3×10\^9/L;
    4. Serum total bilirubin > 2×ULN;
    5. Albumin \< 35 g/L;
    6. Estimated glomerular filtration rate (eGFR) ≤ 60 ml·min-¹·(1.73m²)-¹ ;
    7. International Normalized Ratio (INR) of prothrombin time > 1.5;
  9. Lactating females or participants with a positive pregnancy test;
  10. Participants with any other conditions deemed inappropriate for participation in this trial by the investigator.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
576 participants (estimated)

Study arms

  • Experimental
    GST-HG141

    GST-HG141+NAs

    Drug: GST-HG141

Interventions

  • DrugGST-HG141

    GST-HG141 50 mg BID + NAs

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What researchers measure

Primary outcomes

  1. To evaluate the safety of GST-HG141 combined with NAs treatment

    Treatment-emergent AE incidence rate

    Time frame: up to 52 weeks

Secondary outcomes

  1. 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

  2. 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

  3. The percentage of participants with serum HBV DNA < 20 IU/mL at each visit time point.

    Time frame: up to 48 weeks

  4. The percentage of participants with serum HBV DNA < 10 IU/mL at each visit time point.

    Time frame: up to 48 weeks

  5. Changes from baseline in quantitative serum HBV DNA levels at each visit time point.

    Time frame: up to 48 weeks

  6. Time to achieve serum HBV DNA < 20 IU/mL in each group.

    Time frame: up to 48 weeks

  7. The percentage of participants with serum HBsAg seroclearance at each visit time point.

    Time frame: up to 48 weeks

  8. Changes from baseline in quantitative hepatitis B surface antigen (HBsAg) levels at each visit time point.

    Time frame: up to 48 weeks

  9. 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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07588009
Lead sponsor
Fujian Akeylink Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
May 14, 2026
Start date
Jun 26, 2026 (estimated)
Primary completion
Jan 11, 2028 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
May 14, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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