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 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 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, Buenos Aires C1061AAS
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1125ABE
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires 3435910, 1061
ArgentinaSite Not Available
GSK Investigational Site
Capital Federal, C1181ACI
ArgentinaSite Not Available
GSK Investigational Site
Derqui 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, 08270-070
BrazilSite Not Available
GSK Investigational Site
São Paulo 3448439, 08270-070
BrazilSite Not Available
GSK Investigational Site
Vila Mariana, 04121-000
BrazilSite Not Available
GSK Investigational Site
Sofia,
BulgariaSite Not Available
GSK Investigational Site
Sofia 727011,
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 H2X 0A9
CanadaSite Not Available
GSK Investigational Site
Québec, Quebec G1V 4G2
CanadaSite Not Available
GSK Investigational Site
Saint-Jérôme, Quebec J7Z 2V4
CanadaSite Not Available
GSK Investigational Site
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaSite Not Available
GSK Investigational Site
Beijing, 100015
ChinaSite Not Available
GSK Investigational Site
Beijing 1816670, 100050
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, 510515
ChinaSite Not Available
GSK Investigational Site
Guangzhou 1809858, 510060
ChinaSite Not Available
GSK Investigational Site
Hangzhou, 310022
ChinaSite Not Available
GSK Investigational Site
Hangzhou 1808926, 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
Shanghai 1796236, 200025
ChinaSite Not Available
GSK Investigational Site
Shenyang, 110022
ChinaSite Not Available
GSK Investigational Site
Shenzhen, 518112
ChinaSite Not Available
GSK Investigational Site
Wuhan, 430022
ChinaSite Not Available
GSK Investigational Site
Xi'an, 710061
ChinaSite Not Available
GSK Investigational Site
Zhengzhou, 450000
ChinaSite Not Available
GSK Investigational Site
Zhenjiang,
ChinaSite Not Available
GSK Investigational Site
Ürümqi, 830054
ChinaSite Not Available
GSK Investigational Site
Clermont-Ferrand, 63003
FranceSite Not Available
GSK Investigational Site
Clichy, 92118
FranceSite Not Available
GSK Investigational Site
Clichy Cedex, 92118
FranceActive - Recruiting
GSK Investigational Site
Dijon, 21079
FranceSite Not Available
GSK Investigational Site
Lille, 59037
FranceSite Not Available
GSK Investigational Site
Pessac, 33604
FranceSite Not Available
GSK Investigational Site
Poitiers, 86021
FranceSite Not Available
GSK Investigational Site
Rennes, 35033
FranceSite Not Available
GSK Investigational Site
Strasbourg, 67091
FranceSite Not Available
GSK Investigational Site
Toulouse, 31059
FranceSite Not Available
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen 40225
GermanySite Not Available
GSK Investigational Site
Koeln, Nordrhein-Westfalen 50668
GermanySite Not Available
GSK Investigational Site
Berlin, 12163
GermanySite Not Available
GSK Investigational Site
Berlin 2950159, 10439
GermanySite Not Available
GSK Investigational Site
Bochum, 44787
GermanySite Not Available
GSK Investigational Site
Cologne, 50668
GermanySite Not Available
GSK Investigational Site
Düsseldorf, 40225
GermanySite Not Available
GSK Investigational Site
München, 80336
GermanySite Not Available
GSK Investigational Site
Athens, 11527
GreeceSite Not Available
GSK Investigational Site
Athens 264371, 10676
GreeceSite Not Available
GSK Investigational Site
Periohi Dragana Alexand, 68100
GreeceSite Not Available
GSK Investigational Site
Rio Patras, 26504
GreeceSite Not Available
GSK Investigational Site
Kowloon,
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
Mumbai, 400 008
IndiaSite Not Available
GSK Investigational Site
Mumbai 1275339, 400012
IndiaSite Not Available
GSK Investigational Site
Pune, 411001
IndiaSite Not Available
GSK Investigational Site
Surat, 395002
IndiaSite 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
Milan, 20122
ItalySite Not Available
GSK Investigational Site
Milan 6951411, 20122
ItalySite Not Available
GSK Investigational Site
Milano, 20162
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
Fukuoka 1863967, 839-0863
JapanSite Not Available
GSK Investigational Site
Gifu, 500-8717
JapanSite Not Available
GSK Investigational Site
Gifu 1863641, 503-8502
JapanSite Not Available
GSK Investigational Site
Hiroshima, 734-8551
JapanSite Not Available
GSK Investigational Site
Hiroshima 1862415, 737-0023
JapanSite Not Available
GSK Investigational Site
Hokkaido, 053-8506
JapanSite Not Available
GSK Investigational Site
Hyōgo, 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
Tokyo 1850147, 173-8610
JapanSite Not Available
GSK Investigational Site
Daegu, 700-721
Korea, Republic ofSite Not Available
GSK Investigational Site
Seoul, 03080
Korea, Republic ofSite Not Available
GSK Investigational Site
George Town,
MalaysiaSite Not Available
GSK Investigational Site
Johor Bahru, 80100
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
Kuantan,
MalaysiaSite Not Available
GSK Investigational Site
Guadalajara, 44160
MexicoSite Not Available
GSK Investigational Site
Oaxaca City, 68000
MexicoSite 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
Łańcut, 37-100
PolandSite Not Available
GSK Investigational Site
Bucharest, 021105
RomaniaSite Not Available
GSK Investigational Site
Bucharest 683506, 20125
RomaniaSite Not Available
GSK Investigational Site
Cluj-Napoca, 400162
RomaniaSite Not Available
GSK Investigational Site
Iași, 700116
RomaniaSite Not Available
GSK Investigational Site
Suceava, 720224
RomaniaSite Not Available
GSK Investigational Site
Timișoara, 300001
RomaniaSite Not Available
GSK Investigational Site
Singapore, 169608
SingaporeSite Not Available
GSK Investigational Site
Singapore 1880252, 119074
SingaporeSite Not Available
GSK Investigational Site
Ansan, 15355
South KoreaSite Not Available
GSK Investigational Site
Busan, 47392
South KoreaSite Not Available
GSK Investigational Site
Daegu, 41944
South KoreaSite Not Available
GSK Investigational Site
Daegu 1835329, 42601
South KoreaSite Not Available
GSK Investigational Site
Seoul, 03080
South KoreaSite Not Available
GSK Investigational Site
Seoul 1835848, 06351
South KoreaSite Not Available
GSK Investigational Site
Barcelona, 08036
SpainSite Not Available
GSK Investigational Site
Barcelona 3128760, 08035
SpainSite Not Available
GSK Investigational Site
León, 24080
SpainSite Not Available
GSK Investigational Site
Madrid, 28041
SpainSite Not Available
GSK Investigational Site
Málaga, 29010
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, 833
TaiwanSite Not Available
GSK Investigational Site
Kaohsiung City 1673820, 833
TaiwanSite Not Available
GSK Investigational Site
Taichung, 40705
TaiwanSite Not Available
GSK Investigational Site
Taipei, 104
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
Turkey (Türkiye)Site 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 West Yorkshire, LS9 7TF
United KingdomSite Not Available
GSK Investigational Site
London, SW17 0QT
United KingdomSite Not Available
GSK Investigational Site
London 2643743, SW17 0QT
United KingdomSite Not Available
GSK Investigational Site
Chandler, Arizona 85224
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
San Jose, California 95116
United StatesSite Not Available
GSK Investigational Site
Littleton, Colorado 80120
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
Richmond, Virginia 23298
United StatesSite Not Available
GSK Investigational Site
Richmond 4781708, Virginia 6254928 23249
United StatesSite Not Available

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