Clinical Trials List
Protocol Number219288 (B-Well 2)
NCT Number(ClinicalTrials.gov Identfier)NCT05630820
2023-01-05 - 2026-12-31
Phase III
Terminated4
ICD-10B18.1
Chronic viral hepatitis B without delta-agent
ICD-9070.32
Viral hepatitis B without mention of hepatic coma, chronic, without mention of hepatitis delta
Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B Virus (B-Well 2)
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Trial Applicant
GlaxoSmithKline
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- PEI-JER CHEN Digestive System Department
- 楊宏志 無
- 蘇東弘 Digestive System Department
- 洪俊銘 Digestive System Department
- Jia-Horng Kao Digestive System Department
- 曾岱宗 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Hsueh-Chou Lai Digestive System Department
- Hung-Wei Wang Digestive System Department
- Wei-Fan Hsu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chiu Hung Chiu Digestive System Department
- Hsin-Yu Kuo Digestive System Department
- 吳毅晉 Digestive System Department
- 邱彥程 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Chronic Hepatitis B
Objectives
Main evaluation indicators
Efficacy: Evaluate the effectiveness of bepirovirsen (including loading dose) for 24 weeks in achieving functional cure in subjects with chronic HBV infection, HBeAg negative, receiving NA treatment, and basal phase HBsAg ≤ 1000 IU/mL. Treatment effectiveness in terms of target
Test Drug
GSK3228836/Bepirovirsen
Active Ingredient
Bepirovirsen
Dosage Form
Solution for injection
Dosage
150 mg/mL; 1.0 mL nominal volume per vial
Endpoints
Main evaluation indicators
Efficacy: To evaluate the effectiveness of bepirovirsen (including loading dose) for 24 weeks of treatment in subjects with chronic HBV infection, HBeAg negative, receiving NA treatment, and basal phase HBsAg 1000 IU/mL to achieve the goal of functional cure. therapeutic effects
Efficacy: To evaluate the effectiveness of bepirovirsen (including loading dose) for 24 weeks of treatment in subjects with chronic HBV infection, HBeAg negative, receiving NA treatment, and basal phase HBsAg 1000 IU/mL to achieve the goal of functional cure. therapeutic effects
Inclution Criteria
Inclusion Criteria:
Participants who have documented chronic HBV infection ≥6 months prior to screening and currently receiving stable NA therapy defined as no changes to their NA regimen from at least 6 months prior to Screening and with no planned changes to the stable regimen over the duration of the study.
Plasma or serum HBsAg concentration >100 IU/mL, but no greater than ≤3000 IU/mL.
Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 IU/mL.
Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN).
Participants who are willing and able to cease their NA treatment in accordance with the protocol.
Participants who have documented chronic HBV infection ≥6 months prior to screening and currently receiving stable NA therapy defined as no changes to their NA regimen from at least 6 months prior to Screening and with no planned changes to the stable regimen over the duration of the study.
Plasma or serum HBsAg concentration >100 IU/mL, but no greater than ≤3000 IU/mL.
Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 IU/mL.
Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN).
Participants who are willing and able to cease their NA treatment in accordance with the protocol.
Exclusion Criteria
Exclusion Criteria:
Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate severe liver disease other than chronic HBV, acute coronary syndrome within 6 months of screening, major surgery within 3 months of screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy) or physical examination.
Co-infection with:
a) Current history of Hepatitis C infection or participants that have been cured for <12 months at the time of screening b) Human immunodeficiency virus (HIV), c) Hepatitis D virus.
History of or suspected liver cirrhosis and/or evidence of cirrhosis.
Diagnosed or suspected hepatocellular carcinoma.
History of malignancy within the past 5 years except for specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.
History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
History of alcohol or drug abuse/dependence.
Currently taking, or took within 3 months of screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (≤2 weeks) or topical/inhaled steroid use.
Participants to whom immunosuppressive treatment, including therapeutic doses of steroids is contraindicated, should not be considered for enrolment in the study.
Currently taking, or has taken within 12 months of Screening, any interferon containing therapy.
Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of the study, by the discretion of the investigator. Occasional use is permitted.
Prior treatment with any oligonucleotide or siRNA within 12 months prior to the first dosing day.
Prior treatment with bepirovirsen.
Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate severe liver disease other than chronic HBV, acute coronary syndrome within 6 months of screening, major surgery within 3 months of screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy) or physical examination.
Co-infection with:
a) Current history of Hepatitis C infection or participants that have been cured for <12 months at the time of screening b) Human immunodeficiency virus (HIV), c) Hepatitis D virus.
History of or suspected liver cirrhosis and/or evidence of cirrhosis.
Diagnosed or suspected hepatocellular carcinoma.
History of malignancy within the past 5 years except for specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.
History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
History of alcohol or drug abuse/dependence.
Currently taking, or took within 3 months of screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (≤2 weeks) or topical/inhaled steroid use.
Participants to whom immunosuppressive treatment, including therapeutic doses of steroids is contraindicated, should not be considered for enrolment in the study.
Currently taking, or has taken within 12 months of Screening, any interferon containing therapy.
Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of the study, by the discretion of the investigator. Occasional use is permitted.
Prior treatment with any oligonucleotide or siRNA within 12 months prior to the first dosing day.
Prior treatment with bepirovirsen.
The Estimated Number of Participants
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Taiwan
100 participants
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Global
1050 participants
