Clinical Trials List
Protocol Number218309
NCT Number(ClinicalTrials.gov Identfier)NCT06537414
Active
2024-11-01 - 2028-06-30
Phase II
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
A Phase 2b, multi-centre, randomized, partially placebo-controlled, double-blind study to investigate the safety and efficacy of sequential therapy with daplusiran/tomligisiran followed by bepirovirsen in participants with chronic hepatitis B virus on background nucleos(t)ide analogue therapy (B-United)
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Trial Applicant
GlaxoSmithKline
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Sponsor
GLAXOSMITHKLINE FAR EAST B.V., TAIWAN BRANCH
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Lung Yu 無
- Chung-Feng Huang 無
- Chia-Yen Dai 無
- 梁博程 無
- Ming-Lun Yeh 無
- Jee-Fu Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wen-Juei Jeng
Co-Principal Investigator
- I-Shyan Sheen
- Chao-Wei Hsu
- 滕威 無
- Rong-Nan Chien 無
- Chun-Yen Lin
- Chien-Hao Huang 無
- 戴達英 無
- 林伯庭
- 陳正仁
- 鄭雅婷 無
- Chung-Wei Su 無
- 徐正二
- 劉彥君 無
- Yi-Chung Hsieh 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
chronic hepatitis B
Objectives
The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy.
Test Drug
Daplusiran/Tomligisiran (GSK5637608)
Bepirovirsen (GSK3228836)
Bepirovirsen (GSK3228836)
Active Ingredient
Daplusiran/Tomligisiran (GSK5637608)
Bepirovirsen (GSK3228836)
Bepirovirsen (GSK3228836)
Dosage Form
Solution for injection
Solution for injection
Solution for injection
Dosage
200 mg/mL
150 mg/mL
150 mg/mL
Endpoints
The functional cure for Hepatitis B virus (HBV) is defined as sustained suppression (24 weeks or longer) of HBV deoxyribonucleic acid (DNA)
Inclution Criteria
Inclusion Criteria:
1. Age: At least 18 years of age at the time of signing the informed consent.
2. Documented chronic HBV infection >=6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen form at least 6 months prior to Screening and with no planned changes to their stable regimen over the duration of the study.
3. Plasma or serum HBsAg concentration >100 international units per milliliter (IU/mL)
4. Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 IU/mL.
5. Alanine aminotransferase <=2* upper limit of normal (ULN)
6. Participants who are willing and able to cease their NA treatment in accordance with the protocol.
7. Male and Female
1. Age: At least 18 years of age at the time of signing the informed consent.
2. Documented chronic HBV infection >=6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen form at least 6 months prior to Screening and with no planned changes to their stable regimen over the duration of the study.
3. Plasma or serum HBsAg concentration >100 international units per milliliter (IU/mL)
4. Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA <90 IU/mL.
5. Alanine aminotransferase <=2* upper limit of normal (ULN)
6. Participants who are willing and able to cease their NA treatment in accordance with the protocol.
7. Male and Female
Exclusion Criteria
Exclusion Criteria:
1. 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 coagulopathy) or clinically significant physical examination findings.
2. Coinfection with Hepatitis C (cured <12 months at the time of screening), Human immunodeficiency virus or hepatitis D virus.
3. History of or suspected liver cirrhosis and/or evidence of cirrhosis.
4. Diagnosed or suspected hepatocellular carcinoma.
5. History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (example, skin cancer). Participants under evaluation for possible malignancy are not eligible.
6. 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), current or history of an autoimmune condition or history/presence of other diseases that may be associated with vasculitis condition (example, systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
7. History of extrahepatic disorders possibly related to HBV immune conditions (example, nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
8. History of alcohol or drug abuse/dependence:
9. Currently taking, or took within 3 months of screening, any immunosuppressing drugs (example, prednisone), other than a short course of therapy (<=2 weeks) or topical/inhaled steroid use.
10. Participants, to whom immunosuppressive treatment (including therapeutic doses of steroids) is contraindicated, should not be considered for enrollment in the study.
11. Currently taking, or has taken within 6 months of Screening, any interferon-containing therapy.
12. Participants requiring anti-coagulation therapies (example, warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of Investigational medicinal product (IMP) treatment, by the discretion of the investigator. Occasional use is permitted.
13. Prior hepatitis B treatment with bepirovirsen, DAP/TOM, or another oligonucleotide or small interfering ribonucleic acid (RNA) (siRNA).
14. Prior non-hepatitis B treatment with an oligonucleotide or siRNA within 12 months prior to the first dosing day.
15. Fridericia's QT correction formula (QTcF) >=450 millisecond (msec) (if single electrocardiogram [ECG] at screening shows QTcF >=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion).
16. History of/sensitivity to bepirovirsen, DAP/TOM or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
17. Participants who do not wish to discontinue taking NA therapy for their chronic HBV infection.
1. 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 coagulopathy) or clinically significant physical examination findings.
2. Coinfection with Hepatitis C (cured <12 months at the time of screening), Human immunodeficiency virus or hepatitis D virus.
3. History of or suspected liver cirrhosis and/or evidence of cirrhosis.
4. Diagnosed or suspected hepatocellular carcinoma.
5. History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (example, skin cancer). Participants under evaluation for possible malignancy are not eligible.
6. 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), current or history of an autoimmune condition or history/presence of other diseases that may be associated with vasculitis condition (example, systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
7. History of extrahepatic disorders possibly related to HBV immune conditions (example, nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
8. History of alcohol or drug abuse/dependence:
9. Currently taking, or took within 3 months of screening, any immunosuppressing drugs (example, prednisone), other than a short course of therapy (<=2 weeks) or topical/inhaled steroid use.
10. Participants, to whom immunosuppressive treatment (including therapeutic doses of steroids) is contraindicated, should not be considered for enrollment in the study.
11. Currently taking, or has taken within 6 months of Screening, any interferon-containing therapy.
12. Participants requiring anti-coagulation therapies (example, warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of Investigational medicinal product (IMP) treatment, by the discretion of the investigator. Occasional use is permitted.
13. Prior hepatitis B treatment with bepirovirsen, DAP/TOM, or another oligonucleotide or small interfering ribonucleic acid (RNA) (siRNA).
14. Prior non-hepatitis B treatment with an oligonucleotide or siRNA within 12 months prior to the first dosing day.
15. Fridericia's QT correction formula (QTcF) >=450 millisecond (msec) (if single electrocardiogram [ECG] at screening shows QTcF >=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion).
16. History of/sensitivity to bepirovirsen, DAP/TOM or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
17. Participants who do not wish to discontinue taking NA therapy for their chronic HBV infection.
The Estimated Number of Participants
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Taiwan
25 participants
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Global
280 participants
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