Clinical Trials List
Protocol Number219288(B-Well 2)
NCT Number(ClinicalTrials.gov Identfier)NCT05630820
2023-01-05 - 2026-12-31
Phase III
Recruiting4
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
2025/11/11
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- PEI-JER CHEN Digestive System Department
- Chun-Jen Liu
- 洪俊銘 Digestive System Department
- Jia-Horng Kao Digestive System Department
- 曾岱宗 Digestive System Department
- 蘇東弘 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Ting-Tsung Chang
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Hepatitis B、Hepatitis B, Chronic
Objectives
Primary Efficacy Scale
Efficacy: Evaluate the efficacy of bepirovirsen (including loading dose) for 24 weeks in achieving functional cure in subjects with chronic HBV infection, HBeAg negative, receiving norepinephrine (NA) therapy, and with a baseline HBsAg level ≥1000 IU/mL.
Key Secondary Efficacy Scale
— Evaluate the efficacy of bepirovirsen (including loading dose) for 24 weeks in achieving functional cure in subjects with chronic HBV infection, HBeAg negative, receiving NA therapy, and with a baseline HBsAg level ≥3000 IU/mL.
— Evaluate the efficacy of bepirovirsen (including loading dose) for 24 weeks in achieving HBV DNA suppression after the end of the defined treatment period and cessation of treatment in subjects with chronic HBV infection, HBeAg negative, receiving NA therapy, and with a baseline HBsAg level ≥1000 IU/mL.
— This study evaluated the efficacy of bepirovirsen (including a loading dose) in HBV DNA suppression after 24 weeks of treatment with a controlled dose of bepirovirsen, in subjects with chronic HBV infection, HBeAg negative, receiving norepinephrine (NA) therapy, and with a baseline HBsAg level of ≥3000 IU/mL.
Safety Assessment: The safety and tolerability of bepirovirsen (including a loading dose) administered over a 24-week period were evaluated in subjects with chronic HBV infection, HBeAg negative, and receiving norepinephrine (NA) therapy.
Test Drug
GSK3228836/Bepirovirsen
Active Ingredient
Bepirovirsen
Dosage Form
Solution for injection
Dosage
150 mg/mL; 1.0 mL nominal volume per vial
Endpoints
The primary objective of this trial is to confirm the efficacy, safety, pharmacokinetics, and persistence of bepirovirsen in inhibiting hepatitis B surface antigen compared to placebo after 24 weeks of treatment (including a loading dose). This trial will have the following phases:
(1) Double-blind treatment phase: Participants will receive treatment (bepirovirsen or placebo) for 24 consecutive weeks.
(2) NA monotherapy phase: After completing the double-blind treatment phase, participants will receive NA monotherapy for 24 weeks.
(3) At week 48, participants will be assessed to determine eligibility to discontinue NA treatment and proceed to a 48-week observation period.
3-1: If eligibility is met, NA treatment will be discontinued, and the 48-week observation period will begin.
3-2: If eligibility is not met, NA treatment will continue for another 24 weeks.
This trial is expected to involve each participant for up to 102 weeks (including a maximum 45-day screening period, a 24-week double-blind treatment phase, a 24-week NA monotherapy phase, and a 48-week NA discontinuation and observation phase).
(1) Double-blind treatment phase: Participants will receive treatment (bepirovirsen or placebo) for 24 consecutive weeks.
(2) NA monotherapy phase: After completing the double-blind treatment phase, participants will receive NA monotherapy for 24 weeks.
(3) At week 48, participants will be assessed to determine eligibility to discontinue NA treatment and proceed to a 48-week observation period.
3-1: If eligibility is met, NA treatment will be discontinued, and the 48-week observation period will begin.
3-2: If eligibility is not met, NA treatment will continue for another 24 weeks.
This trial is expected to involve each participant for up to 102 weeks (including a maximum 45-day screening period, a 24-week double-blind treatment phase, a 24-week NA monotherapy phase, and a 48-week NA discontinuation and observation phase).
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.
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.
The Estimated Number of Participants
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Taiwan
100 participants
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Global
534 participants
