Phase
Condition
Hepatitis B
Hepatitis
Liver Disorders
Treatment
Placebo
Bepirovirsen
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants who have documented chronic HBV infection ≥6 months prior to screeningand currently receiving stable NA therapy defined as no changes to their NA regimenfrom at least 6 months prior to Screening and with no planned changes to the stableregimen 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 asplasma 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 withthe protocol.
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 diathesis orcoagulopathy) 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 arecured by surgical resection (e.g., skin cancer). Participants under evaluation forpossible 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 (e.g., systemiclupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritismultiplex).
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) ortopical/inhaled steroid use.
Participants to whom immunosuppressive treatment, including therapeutic doses ofsteroids is contraindicated, should not be considered for enrolment in the study.
Currently taking, or has taken within 12 months of Screening, any interferoncontaining therapy.
Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xainhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatmentcan safely be discontinued throughout duration of the study, by the discretion ofthe investigator. Occasional use is permitted.
Prior treatment with any oligonucleotide or siRNA within 12 months prior to thefirst dosing day.
Prior treatment with bepirovirsen.
Study Design
Connect with a study center
GSK Investigational Site
CABA-Ciudad De Buenos Aires, Buenos Aires C1125ABE
ArgentinaSite Not Available
GSK Investigational Site
Caba, Buenos Aires 1061
ArgentinaSite Not Available
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires C1181ACI
ArgentinaSite Not Available
GSK Investigational Site
Derqui, Pilar, Buenos Aires B1629AHJ
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1061AAS
ArgentinaSite Not Available
GSK Investigational Site
Capital Federal, C1181ACI
ArgentinaSite Not Available
GSK Investigational Site
Pilar, B1629AHJ
ArgentinaSite Not Available
GSK Investigational Site
Rosario, S2002KDT
ArgentinaSite Not Available
GSK Investigational Site
Aracaju, 49060-010
BrazilSite Not Available
GSK Investigational Site
Campinas, 13034-685
BrazilSite Not Available
GSK Investigational Site
Curitiba, 80810-050
BrazilSite Not Available
GSK Investigational Site
Manaus, 69040-000
BrazilSite Not Available
GSK Investigational Site
Porto Alegre, 90035003
BrazilSite Not Available
GSK Investigational Site
Santa Maria, 97105-900
BrazilSite Not Available
GSK Investigational Site
Sao Paulo, 08270-070
BrazilSite Not Available
GSK Investigational Site
São Paulo, 04121-000
BrazilSite Not Available
GSK Investigational Site
Vila Mariana, 04121-000
BrazilSite Not Available
GSK Investigational Site
Sofia,
BulgariaSite Not Available
GSK Investigational Site
Veliko Tarnovo, 5000
BulgariaSite Not Available
GSK Investigational Site
Vancouver, British Columbia V6Z 2K5
CanadaSite Not Available
GSK Investigational Site
Victoria, British Columbia V8V 3M9
CanadaSite Not Available
GSK Investigational Site
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
GSK Investigational Site
Toronto, Ontario M5G 2C4
CanadaSite Not Available
GSK Investigational Site
Montreal, Quebec H4A 3J1
CanadaSite Not Available
GSK Investigational Site
Quebec City, Quebec G1V 4G2
CanadaSite Not Available
GSK Investigational Site
Saint Jerome, Quebec J7Z 2V4
CanadaSite Not Available
GSK Investigational Site
St-Jerome, Quebec J7Z 2V4
CanadaSite Not Available
GSK Investigational Site
Québec, G1V 4G2
CanadaSite Not Available
GSK Investigational Site
Urumqi, Xinjiang 830054
ChinaSite Not Available
GSK Investigational Site
Beijing,
ChinaSite Not Available
GSK Investigational Site
Changchun, 130021
ChinaSite Not Available
GSK Investigational Site
Chengdu,
ChinaSite Not Available
GSK Investigational Site
Chongqing, 400042
ChinaSite Not Available
GSK Investigational Site
Fuzhou, 350025
ChinaSite Not Available
GSK Investigational Site
Guangzhou, 510060
ChinaSite Not Available
GSK Investigational Site
Hangzhou, 310003
ChinaSite Not Available
GSK Investigational Site
Kunming, 650021
ChinaSite Not Available
GSK Investigational Site
Nanjing, 210008
ChinaSite Not Available
GSK Investigational Site
Shanghai, 200025
ChinaSite Not Available
GSK Investigational Site
Shenyang, 110022
ChinaSite Not Available
GSK Investigational Site
Shenzhen, 518023
ChinaSite Not Available
GSK Investigational Site
Urumchi, 830054
ChinaSite Not Available
GSK Investigational Site
Wuhan, 430022
ChinaSite Not Available
GSK Investigational Site
Xi'an, 710061
ChinaSite Not Available
GSK Investigational Site
Xian, 710061
ChinaSite Not Available
GSK Investigational Site
Zhengzhou, 450000
ChinaSite Not Available
GSK Investigational Site
Zhenjiang,
ChinaSite Not Available
GSK Investigational Site
Clermont-Ferrand, 63003
FranceSite Not Available
GSK Investigational Site
Clermont-Ferrand Cedex 1, 63003
FranceSite Not Available
GSK Investigational Site
Clichy Cedex, 92118
FranceSite Not Available
GSK Investigational Site
Dijon, 21079
FranceSite Not Available
GSK Investigational Site
Dijon Cedex, 21079
FranceSite Not Available
GSK Investigational Site
Lille, 59037
FranceSite Not Available
GSK Investigational Site
Lille cedex, 59037
FranceSite Not Available
GSK Investigational Site
Pessac cedex, 33604
FranceSite Not Available
GSK Investigational Site
Poitiers, 86021
FranceSite Not Available
GSK Investigational Site
Rennes, 35033
FranceSite Not Available
GSK Investigational Site
Rennes cedex 09, 35033
FranceSite Not Available
GSK Investigational Site
Strasbourg, 67091
FranceSite Not Available
GSK Investigational Site
Strasbourg Cedex, 67091
FranceSite Not Available
GSK Investigational Site
Toulouse Cedex 9, 31059
FranceSite Not Available
GSK Investigational Site
Toulouse cedex, 31059
FranceSite Not Available
GSK Investigational Site
Munchen, Bayern 80336
GermanySite Not Available
GSK Investigational Site
Berlin, 10243
GermanySite Not Available
GSK Investigational Site
Bochum, 44787
GermanySite Not Available
GSK Investigational Site
Duesseldorf, 40225
GermanySite Not Available
GSK Investigational Site
Koeln, 50668
GermanySite Not Available
GSK Investigational Site
Muenchen, 80336
GermanySite Not Available
GSK Investigational Site
Alexandroupolis, 68100
GreeceSite Not Available
GSK Investigational Site
Athens, 10676
GreeceSite Not Available
GSK Investigational Site
Periohi Dragana Alexand, 68100
GreeceSite Not Available
GSK Investigational Site
Rio, 26504
GreeceSite Not Available
GSK Investigational Site
Rio Patras, 26504
GreeceSite Not Available
GSK Investigational Site
Kowloon,
Hong KongSite Not Available
GSK Investigational Site
Lai King,
Hong KongSite Not Available
GSK Investigational Site
Pokfulam,
Hong KongSite Not Available
GSK Investigational Site
Shatin,
Hong KongSite Not Available
GSK Investigational Site
Budapest, 1097
HungarySite Not Available
GSK Investigational Site
Eger, 3300
HungarySite Not Available
GSK Investigational Site
Gyula, 5700
HungarySite Not Available
GSK Investigational Site
Miskolc, 3530
HungarySite Not Available
GSK Investigational Site
Belagavi, 590010
IndiaSite Not Available
GSK Investigational Site
Chandigarh, 160012
IndiaSite Not Available
GSK Investigational Site
Chennai, 600113
IndiaSite Not Available
GSK Investigational Site
Coimbatore, 641005
IndiaSite Not Available
GSK Investigational Site
Guhawati, 781006
IndiaSite Not Available
GSK Investigational Site
Hyderabad, 500033
IndiaSite Not Available
GSK Investigational Site
HyderabadTelangana, 500048
IndiaSite Not Available
GSK Investigational Site
Jaipur, 302001
IndiaSite Not Available
GSK Investigational Site
Ludhiana, 141001
IndiaSite Not Available
GSK Investigational Site
Manipal, 576104
IndiaSite Not Available
GSK Investigational Site
Manipala, 576104
IndiaSite Not Available
GSK Investigational Site
Mumbai, 400012
IndiaSite Not Available
GSK Investigational Site
Pune, 411001
IndiaSite Not Available
GSK Investigational Site
Surat, 395002
IndiaSite Not Available
GSK Investigational Site
Baggiovara (MO), Emilia-Romagna 40126
ItalySite Not Available
GSK Investigational Site
Brescia, 25123
ItalySite Not Available
GSK Investigational Site
Foggia, 71100
ItalySite Not Available
GSK Investigational Site
Messina, 98124
ItalySite Not Available
GSK Investigational Site
Milano, 20122
ItalySite Not Available
GSK Investigational Site
Modena, 40126
ItalySite Not Available
GSK Investigational Site
Chiba, 272-8516
JapanSite Not Available
GSK Investigational Site
Ehime, 790-8524
JapanSite Not Available
GSK Investigational Site
Fukuoka, 839-0863
JapanSite Not Available
GSK Investigational Site
Gifu, 500-8717
JapanSite Not Available
GSK Investigational Site
Hiroshima, 737-0023
JapanSite Not Available
GSK Investigational Site
Hokkaido, 053-8506
JapanSite Not Available
GSK Investigational Site
Hyogo, 660-8550
JapanSite Not Available
GSK Investigational Site
Kumamoto, 862-8655
JapanSite Not Available
GSK Investigational Site
Miyagi, 980-8574
JapanSite Not Available
GSK Investigational Site
Tokyo, 180-8610
JapanSite Not Available
GSK Investigational Site
Ansan, 15355
Korea, Republic ofSite Not Available
GSK Investigational Site
Busan, 47392
Korea, Republic ofSite Not Available
GSK Investigational Site
Daegu, 42601
Korea, Republic ofSite Not Available
GSK Investigational Site
Daegu-si, 42601
Korea, Republic ofSite Not Available
GSK Investigational Site
Daejeon, 35015
Korea, Republic ofSite Not Available
GSK Investigational Site
Gyeonggi-do, 15355
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, 03080
Korea, Republic ofSite Not Available
GSK Investigational Site
Georgetown,
MalaysiaSite Not Available
GSK Investigational Site
Johor Bahru, 80100
MalaysiaSite Not Available
GSK Investigational Site
Kota Bharu,
MalaysiaSite Not Available
GSK Investigational Site
Kota Bharu Kelantan,
MalaysiaSite Not Available
GSK Investigational Site
Kota Kinabalu,
MalaysiaSite Not Available
GSK Investigational Site
Kuala Lumpur,
MalaysiaSite Not Available
GSK Investigational Site
Kuala Lumpur,,
MalaysiaSite Not Available
GSK Investigational Site
Kuantan,
MalaysiaSite Not Available
GSK Investigational Site
Monterrey, Nuevo León 64460
MexicoSite Not Available
GSK Investigational Site
Guadalajara, 44160
MexicoSite Not Available
GSK Investigational Site
Oaxaca, 68000
MexicoSite Not Available
GSK Investigational Site
Ciudad de Panama,
PanamaSite Not Available
GSK Investigational Site
Panama City, 07206
PanamaSite Not Available
GSK Investigational Site
Bytom, 41-902
PolandSite Not Available
GSK Investigational Site
Krakow, 31-202
PolandSite Not Available
GSK Investigational Site
Lancut, 37-100
PolandSite Not Available
GSK Investigational Site
Bucharest, 20125
RomaniaSite Not Available
GSK Investigational Site
Bucuresti, 20125
RomaniaSite Not Available
GSK Investigational Site
Cluj Napoca, 400162
RomaniaSite Not Available
GSK Investigational Site
Iasi, 700116
RomaniaSite Not Available
GSK Investigational Site
Suceava, 720224
RomaniaSite Not Available
GSK Investigational Site
Timisoara, 300001
RomaniaSite Not Available
GSK Investigational Site
Singapore, 169608
SingaporeSite Not Available
GSK Investigational Site
Barcelona, 08036
SpainSite Not Available
GSK Investigational Site
Leon, 24080
SpainSite Not Available
GSK Investigational Site
León, 24080
SpainSite Not Available
GSK Investigational Site
Madrid, 28041
SpainSite Not Available
GSK Investigational Site
Malaga, 29010
SpainSite Not Available
GSK Investigational Site
Málaga, 29010
SpainSite Not Available
GSK Investigational Site
Pontevedra, 36002
SpainSite Not Available
GSK Investigational Site
Salamanca, 37007
SpainSite Not Available
GSK Investigational Site
Santander, 39008
SpainSite Not Available
GSK Investigational Site
Valencia, 46014
SpainSite Not Available
GSK Investigational Site
Valladolid, 47003
SpainSite Not Available
GSK Investigational Site
Vigo, 36002
SpainSite Not Available
GSK Investigational Site
Kaohsiung, 833
TaiwanSite Not Available
GSK Investigational Site
Kaohsiung City, 807
TaiwanSite Not Available
GSK Investigational Site
Taichung, 40705
TaiwanSite Not Available
GSK Investigational Site
Taipei, 104
TaiwanSite Not Available
GSK Investigational Site
Taoyuan, 333
TaiwanSite Not Available
GSK Investigational Site
Tau-Yuan, 333
TaiwanSite Not Available
GSK Investigational Site
Bangkok, 10330
ThailandSite Not Available
GSK Investigational Site
Ankara, 06230
TurkeySite Not Available
GSK Investigational Site
Birmingham, B15 2TH
United KingdomSite Not Available
GSK Investigational Site
Edinburgh, EH4 2XU
United KingdomSite Not Available
GSK Investigational Site
Leeds, LS9 7TF
United KingdomSite Not Available
GSK Investigational Site
Leeds West Yorkshire, LS9 7TF
United KingdomSite Not Available
GSK Investigational Site
London, SE5 9RS
United KingdomSite Not Available
GSK Investigational Site
Chandler, Arizona 85224
United StatesSite Not Available
GSK Investigational Site
Tucson, Arizona 85712
United StatesSite Not Available
GSK Investigational Site
Davis, California 95817
United StatesSite Not Available
GSK Investigational Site
Los Angeles, California 90027
United StatesSite Not Available
GSK Investigational Site
Palo Alto, California 94304
United StatesSite Not Available
GSK Investigational Site
Sacramento, California 95817
United StatesSite Not Available
GSK Investigational Site
San Jose, California 95128
United StatesSite Not Available
GSK Investigational Site
Littleton, Colorado 80120
United StatesSite Not Available
GSK Investigational Site
Homestead, Florida 33030
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33134
United StatesSite Not Available
GSK Investigational Site
Iowa City, Iowa 52242
United StatesSite Not Available
GSK Investigational Site
Baltimore, Maryland 21287
United StatesSite Not Available
GSK Investigational Site
Detroit, Michigan 48377
United StatesSite Not Available
GSK Investigational Site
Novi, Michigan 48377
United StatesSite Not Available
GSK Investigational Site
Richmond, Virginia 23249
United StatesSite Not Available
GSK Investigational Site
Hanoi,
VietnamSite Not Available
GSK Investigational Site
Ho Chi Minh City, 700000
VietnamSite Not Available
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