Phase
Condition
Hepatitis B
Liver Disorders
Hepatitis
Treatment
Bepirovirsen
Placebo
Daplusiran/Tomligisiran Dose Level 1
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age: At least 18 years of age at the time of signing the informed consent.
Documented chronic HBV infection >=6 months prior to Screening AND currentlyreceiving stable NA therapy defined as receiving an NA regimen form at least 6months prior to Screening and with no planned changes to their stable regimen overthe duration of the study.
Plasma or serum HBsAg concentration >100 international units per milliliter (IU/mL)
Plasma or serum HBV DNA concentration must be adequately suppressed, defined asplasma or serum HBV DNA <90 IU/mL.
Alanine aminotransferase <=2* upper limit of normal (ULN)
Participants who are willing and able to cease their NA treatment in accordance withthe protocol.
Male and Female
Exclusion
Exclusion Criteria:
Clinically significant abnormalities, aside from chronic HBV infection in medicalhistory (e.g., moderate-severe liver disease other than chronic HBV, acute coronarysyndrome within 6 months of screening, major surgery within 3 months of screening,significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesiscoagulopathy) or clinically significant physical examination findings.
Coinfection with Hepatitis C (cured <12 months at the time of screening), Humanimmunodeficiency virus or 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 with the exception of specific cancersthat are cured by surgical resection (example, skin cancer). Participants underevaluation 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 withoutidentified cause), current or history of an autoimmune condition or history/presenceof other diseases that may be associated with vasculitis condition (example,systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis,mononeuritis multiplex).
History of extrahepatic disorders possibly related to HBV immune conditions (example, 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 (example, prednisone), other than a short course of therapy (<=2 weeks) ortopical/inhaled steroid use.
Participants, to whom immunosuppressive treatment (including therapeutic doses ofsteroids) is contraindicated, should not be considered for enrollment in the study.
Currently taking, or has taken within 6 months of Screening, anyinterferon-containing therapy.
Participants requiring anti-coagulation therapies (example, warfarin, Factor Xainhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatmentcan safely be discontinued throughout duration of Investigational medicinal product (IMP) treatment, by the discretion of the investigator. Occasional use is permitted.
Prior hepatitis B treatment with bepirovirsen, DAP/TOM, or another oligonucleotideor small interfering ribonucleic acid (RNA) (siRNA).
Prior non-hepatitis B treatment with an oligonucleotide or siRNA within 12 monthsprior to the first dosing day.
Fridericia's QT correction formula (QTcF) >=450 millisecond (msec) (if singleelectrocardiogram [ECG] at screening shows QTcF >=450 msec, a mean of triplicatemeasurements should be used to confirm that participant meets exclusion criterion).
History of/sensitivity to bepirovirsen, DAP/TOM or components thereof or a historyof drug or other allergy that, in the opinion of the investigator or MedicalMonitor, contraindicates their participation
Participants who do not wish to discontinue taking NA therapy for their chronic HBVinfection.
Study Design
Connect with a study center
GSK Investigational Site
Camperdown, New South Wales 2050
AustraliaSite Not Available
GSK Investigational Site
Westmead, New South Wales 2145
AustraliaSite Not Available
GSK Investigational Site
Fitzroy, Victoria 3065
AustraliaSite Not Available
GSK Investigational Site
Bruxelles, 1000
BelgiumSite Not Available
GSK Investigational Site
Edegem, 2650
BelgiumSite Not Available
GSK Investigational Site
Gent, 9000
BelgiumSite Not Available
GSK Investigational Site
Aracaju, 49060-010
BrazilSite Not Available
GSK Investigational Site
Curitiba, 80810-050
BrazilSite Not Available
GSK Investigational Site
Manaus, 69040-000
BrazilSite Not Available
GSK Investigational Site
Sao Paulo, 05403-000
BrazilSite Not Available
GSK Investigational Site
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
GSK Investigational Site
Ottawa, Ontario K1H8L6
CanadaSite Not Available
GSK Investigational Site
Toronto, Ontario L4L 4Y7
CanadaSite Not Available
GSK Investigational Site
Montreal, Quebec H4A 3J1
CanadaSite Not Available
GSK Investigational Site
Beijing, 100050
ChinaSite Not Available
GSK Investigational Site
Chengdu, 610072
ChinaSite Not Available
GSK Investigational Site
Guangzhou, 510630
ChinaSite Not Available
GSK Investigational Site
Shanghai, 200040
ChinaSite Not Available
GSK Investigational Site
Zhenjiang,
ChinaSite Not Available
GSK Investigational Site
Clichy Cedex, 92118
FranceSite Not Available
GSK Investigational Site
CrEteil cedex, 94010
FranceSite Not Available
GSK Investigational Site
Limoges cedex, 87042
FranceSite Not Available
GSK Investigational Site
Lyon, 69004
FranceSite Not Available
GSK Investigational Site
Marseille, 13008
FranceSite Not Available
GSK Investigational Site
Toulouse Cedex 9, 31059
FranceSite Not Available
GSK Investigational Site
Berlin, 10787
GermanySite Not Available
GSK Investigational Site
Essen, 45122
GermanySite Not Available
GSK Investigational Site
Hannover, 30625
GermanySite Not Available
GSK Investigational Site
Leipzig, 04103
GermanySite Not Available
GSK Investigational Site
Muenster, 48149
GermanySite Not Available
GSK Investigational Site
Athens, 11527
GreeceSite Not Available
GSK Investigational Site
Pokfulam,
Hong KongSite Not Available
GSK Investigational Site
Shatin,
Hong KongSite Not Available
GSK Investigational Site
Bergamo, 24127
ItalySite Not Available
GSK Investigational Site
Firenze, 50134
ItalySite Not Available
GSK Investigational Site
Milano,
ItalySite Not Available
GSK Investigational Site
Modena, 41126
ItalySite Not Available
GSK Investigational Site
Napoli, 80131
ItalySite Not Available
GSK Investigational Site
Padova, 35131
ItalySite Not Available
GSK Investigational Site
Pisa, 56124
ItalySite Not Available
GSK Investigational Site
Roma, 00161
ItalySite Not Available
GSK Investigational Site
Torino, 10126
ItalySite Not Available
GSK Investigational Site
Chiba, 270-1694
JapanSite Not Available
GSK Investigational Site
Hokkaido, 006-8555
JapanSite Not Available
GSK Investigational Site
Hyogo, 660-8550
JapanSite Not Available
GSK Investigational Site
Kagawa, 761-0793
JapanSite Not Available
GSK Investigational Site
Kumamoto, 860-8556
JapanSite Not Available
GSK Investigational Site
Osaka, 540-0006
JapanSite Not Available
GSK Investigational Site
Tokyo, 180-8610
JapanSite Not Available
GSK Investigational Site
Yamanashi, 409-3898
JapanSite Not Available
GSK Investigational Site
Ansan, 15355
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Busan, 47392
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Pusan, 49241
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Seoul, 138-736
Korea, Republic ofSite Not Available
GSK Investigational Site
Auckland, 1023
New ZealandSite Not Available
GSK Investigational Site
Papatoetoe Auckland, 2025
New ZealandSite Not Available
GSK Investigational Site
Singapore, 169608
SingaporeSite Not Available
GSK Investigational Site
Johannesburg, 2193
South AfricaSite Not Available
GSK Investigational Site
Reiger Park, 1459
South AfricaSite Not Available
GSK Investigational Site
Soweto Johannesburg, 2013
South AfricaSite Not Available
GSK Investigational Site
Barcelona, 08035
SpainSite Not Available
GSK Investigational Site
Leon, 24080
SpainSite Not Available
GSK Investigational Site
Madrid, 28041
SpainSite Not Available
GSK Investigational Site
Salamanca, 37007
SpainSite Not Available
GSK Investigational Site
Santander, 39008
SpainSite Not Available
GSK Investigational Site
Valencia, 46026
SpainSite Not Available
GSK Investigational Site
Kaohsiung, 824
TaiwanSite Not Available
GSK Investigational Site
Kaohsiung City, 807
TaiwanSite Not Available
GSK Investigational Site
Taichung, 404
TaiwanSite Not Available
GSK Investigational Site
Tau-Yuan, 333
TaiwanSite Not Available
GSK Investigational Site
London, SE5 9RS
United KingdomSite Not Available
GSK Investigational Site
Middlesbrough, TS4 3BW
United KingdomSite Not Available
GSK Investigational Site
San Francisco, California 94115
United StatesActive - Recruiting
GSK Investigational Site
San Jose, California 95128
United StatesSite Not Available
GSK Investigational Site
Minneapolis, Minnesota 55415
United StatesSite Not Available
GSK Investigational Site
New York, New York 10029
United StatesSite Not Available
GSK Investigational Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
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