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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GST-HG141 | Experimental | GST-HG141+NAs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GST-HG141 | Drug | GST-HG141 50 mg BID + NAs |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of GST-HG141 combined with NAs treatment | Treatment-emergent AE incidence rate | up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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;
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:
Lactating females or participants with a positive pregnancy test;
Participants with any other conditions deemed inappropriate for participation in this trial by the investigator.
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| up to 48 weeks |
| The percentage of participants with serum HBV DNA < 20 IU/mL at each visit time point. | up to 48 weeks |
| The percentage of participants with serum HBV DNA < 10 IU/mL at each visit time point. | up to 48 weeks |
| Changes from baseline in quantitative serum HBV DNA levels at each visit time point. | up to 48 weeks |
| Time to achieve serum HBV DNA < 20 IU/mL in each group. | up to 48 weeks |
| The percentage of participants with serum HBsAg seroclearance at each visit time point. | up to 48 weeks |
| Changes from baseline in quantitative hepatitis B surface antigen (HBsAg) levels at each visit time point. | up to 48 weeks |
| Changes from baseline in quantitative serum hepatitis B virus pregenomic RNA (HBV pgRNA) levels at each visit time point. | up to 48 weeks |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |