Phase
Condition
Hepatitis B
Hepatitis
Treatment
Placebo
Bepirovirsen
GSK3228836
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Participants who enter the study on stable NA are willing and able to cease their NAtreatment in accordance with the NA cessation schedule.
Capable of giving informed consent.
For participants rolling over from 209668 (B-Clear), 209348 (B-Together), and 212602 (B-Fine):
- Participants who have previously received at least one dose of bepirovirsen AND
Achieved the PSPO in the parent study and who maintained a response until theEnd of Study (EoS) visit in their parent study (defined as complete respondersto bepirovirsen from the parent study) OR
Demonstrated hepatitis B virus surface antigen (HBsAg) reduction greater thanor equal to (≥) 1.0 log10 international units per milliliter (IU/mL) fromparent study Baseline with HBsAg levels less than (<) 100 IU/mL and HBVdeoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ) for 24 weeksafter the actual end of treatment regimen, in the absence of rescue medicationand maintained until their EoS visit in the parent study.
For participants rolling over from 202009 (B-Well1) and 219288 (B-Well 2):
- Participants who have previously received at least 1 dose of bepirovirsen (ormatching placebo where appropriate) AND
NA cessated at Week 48 in parent study and achieved at least HBsAg <1 IU/ml andHBV DNA <LLOQ at the EOS visit (Week 96) in the parent study OR
Achieved NA cessation criteria at Week 48 in parent study but have not stoppedNA treatment, and are maintaining at least HBsAg <1 IU/ml and HBV DNA <LLOQ atEOS visit (Week 72) of parent study OR
Did not achieve NA cessation criteria in parent study but achieved at leastHBsAg <1 IU/ml and HBV DNA <LLOQ at EOS visit (Week 72) of parent study.
For participants rolling over from 217023 (TH HBV ASO-001):
- Participants who have previously received at least 1 dose of bepirovirsen AND
Achieved HBsAg <1 IU/ml and HBV DNA <LLOQ in parent study at Week 66 (ASO12arm) or Week 78 (ASO 24 arm) and are maintaining HBsAg < 1 IU/ml and HBV DNA <LLOQ, at the EOS study visit [Week 133 ASO12 arm), or Week 145 (ASO24 arm)] inparent study OR
Did not achieve HBsAg <1 IU/ml and HBV DNA <LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO24 arm) but have achieved HBsAg < 1 IU/ml and HBVDNA < LLOQ by the EOS visit (Week 133 (ASO12 arm) or Week 145 (ASO24 arm)) inthe parent study.
Exclusion
Exclusion Criteria:
Participants who have/or are currently participating in another non-GSKinterventional clinical study exploring HBV treatment since completing theirtreatment with bepirovirsen.
Any condition which, in the opinion of the investigator or Medical Monitor,contraindicates their participation in this study.
Study Design
Connect with a study center
GSK Investigational Site
La Plata, Buenos Aires B1902AWL
ArgentinaSite Not Available
GSK Investigational Site
Buenos Aires, C1425AGC
ArgentinaSite Not Available
GSK Investigational Site
Rosario, 2000
ArgentinaSite Not Available
GSK Investigational Site
Santa Fe, 3000
ArgentinaSite Not Available
GSK Investigational Site
Herston, Queensland 4029
AustraliaSite Not Available
GSK Investigational Site
Fitzroy, Victoria 3065
AustraliaSite Not Available
GSK Investigational Site
Aracaju, Sergipe 49055-000
BrazilSite Not Available
GSK Investigational Site
Campinas, 13060-803
BrazilSite Not Available
GSK Investigational Site
Curitiba, 30140-073
BrazilSite Not Available
GSK Investigational Site
Manaus, 69040000
BrazilSite Not Available
GSK Investigational Site
São Paulo, 05403-000
BrazilSite Not Available
GSK Investigational Site
Vila Mariana, 04121-000
BrazilSite Not Available
GSK Investigational Site
Plovdiv, 4000
BulgariaSite Not Available
GSK Investigational Site
Sliven, 8800
BulgariaSite Not Available
GSK Investigational Site
Sofia, 1431
BulgariaSite Not Available
GSK Investigational Site
Varna, 9010
BulgariaSite Not Available
GSK Investigational Site
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
GSK Investigational Site
Victoria, British Columbia V8R 6R3
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
Québec, Quebec G1V 4G2
CanadaSite Not Available
GSK Investigational Site
Beijing, 100015
ChinaSite Not Available
GSK Investigational Site
Chengdu, 610072
ChinaSite Not Available
GSK Investigational Site
Chongqing, 400042
ChinaSite Not Available
GSK Investigational Site
Fuzhou, 350028
ChinaSite Not Available
GSK Investigational Site
Guangzhou, 510440
ChinaSite Not Available
GSK Investigational Site
Hangzhou, 310014
ChinaSite Not Available
GSK Investigational Site
Kunming, 650021
ChinaSite Not Available
GSK Investigational Site
Liuzhou,
ChinaSite Not Available
GSK Investigational Site
Shanghai, 200025
ChinaSite Not Available
GSK Investigational Site
Shenzhen, 518112
ChinaSite Not Available
GSK Investigational Site
Tianjin, 300000
ChinaSite Not Available
GSK Investigational Site
Wuhan, 430030
ChinaSite Not Available
GSK Investigational Site
Xi'an, 710061
ChinaSite Not Available
GSK Investigational Site
Xiamen, 361015
ChinaSite Not Available
GSK Investigational Site
Zhenjiang,
ChinaSite Not Available
GSK Investigational Site
Zunyi, 563114
ChinaSite Not Available
GSK Investigational Site
Ürümqi, 830054
ChinaSite Not Available
GSK Investigational Site
Clichy, 92110
FranceSite Not Available
GSK Investigational Site
Lyon, 69317
FranceSite Not Available
GSK Investigational Site
Paris,
FranceSite Not Available
GSK Investigational Site
Pessac, 33604
FranceSite Not Available
GSK Investigational Site
Rennes, 35000
FranceSite Not Available
GSK Investigational Site
Strasbourg, 67200
FranceSite Not Available
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia 40225
GermanySite Not Available
GSK Investigational Site
Berlin, 12157
GermanySite Not Available
GSK Investigational Site
Frankfurt am Main, 60329
GermanySite Not Available
GSK Investigational Site
Hamburg, 20146
GermanySite Not Available
GSK Investigational Site
Athens, 10676
GreeceSite Not Available
GSK Investigational Site
Heraklion, 711 10
GreeceSite Not Available
GSK Investigational Site
Kowloon,
Hong KongSite Not Available
GSK Investigational Site
Pokfulam,
Hong KongSite Not Available
GSK Investigational Site
Budapest, 1097
HungarySite Not Available
GSK Investigational Site
Belagavi, 590010
IndiaSite Not Available
GSK Investigational Site
Coimbatore, 641005
IndiaSite Not Available
GSK Investigational Site
Hyderabad,
IndiaSite Not Available
GSK Investigational Site
Kanchan Bagh Hyderabad, 40000
IndiaSite Not Available
GSK Investigational Site
Mumbai, 400008
IndiaSite Not Available
GSK Investigational Site
New Delhi, 110070
IndiaSite Not Available
GSK Investigational Site
Pune, 411001
IndiaSite Not Available
GSK Investigational Site
Surat, 395002
IndiaSite Not Available
GSK Investigational Site
Bergamo, 24127
ItalySite Not Available
GSK Investigational Site
Milan, 20122
ItalySite Not Available
GSK Investigational Site
Milano, 20157
ItalyActive - Recruiting
GSK Investigational Site
Modena, 40126
ItalySite Not Available
GSK Investigational Site
Naples, 80131
ItalySite Not Available
GSK Investigational Site
Palermo, 90127
ItalySite Not Available
GSK Investigational Site
Pisa, 56124
ItalySite Not Available
GSK Investigational Site
Gifu, 503-8502
JapanSite Not Available
GSK Investigational Site
Hiroshima, 734-8551
JapanSite Not Available
GSK Investigational Site
Hokkaido, 006-0811
JapanSite Not Available
GSK Investigational Site
Ishikawa, 920-8650
JapanSite Not Available
GSK Investigational Site
Kagawa, 760-8557
JapanSite Not Available
GSK Investigational Site
Kumamoto, 860-8556
JapanSite Not Available
GSK Investigational Site
Miyagi, 980-8574
JapanSite Not Available
GSK Investigational Site
Niigata, 950-1104
JapanSite Not Available
GSK Investigational Site
Osaka, 565-0871
JapanSite Not Available
GSK Investigational Site
Tokyo, 113-8519
JapanSite Not Available
GSK Investigational Site
Yamaguchi, 750-0061
JapanSite Not Available
GSK Investigational Site
Ansan-si Gyenggi-do, 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, 05505
Korea, Republic ofActive - Recruiting
GSK Investigational Site
Kuala Terengganu, 20400
MalaysiaSite Not Available
GSK Investigational Site
Auckland, 01042
New ZealandSite Not Available
GSK Investigational Site
Panama City, 7196
PanamaSite Not Available
GSK Investigational Site
Cebu City, 6000
PhilippinesSite Not Available
GSK Investigational Site
Silang, 4118
PhilippinesSite Not Available
GSK Investigational Site
Gdansk, 80-405
PolandSite Not Available
GSK Investigational Site
Krakow, 31-202
PolandSite Not Available
GSK Investigational Site
Lublin,
PolandSite Not Available
GSK Investigational Site
Mysłowice, 41-400
PolandSite Not Available
GSK Investigational Site
Łańcut, 37-100
PolandSite Not Available
GSK Investigational Site
Żychlin, 62-571
PolandSite Not Available
GSK Investigational Site
Bucharest, 021105
RomaniaSite Not Available
GSK Investigational Site
Craiova Dolj, 417307
RomaniaSite Not Available
GSK Investigational Site
Galati, 800179
RomaniaSite Not Available
GSK Investigational Site
Oradea, 410469
RomaniaSite Not Available
GSK Investigational Site
Chelyabinsk, 454052
RussiaSite Not Available
GSK Investigational Site
Moscow, 121170
RussiaSite Not Available
GSK Investigational Site
Novosibirsk, 630099
RussiaSite Not Available
GSK Investigational Site
Saint Petersburg, 191167
RussiaSite Not Available
GSK Investigational Site
Samara, 443063
RussiaSite Not Available
GSK Investigational Site
Красноярск, 660049
RussiaSite Not Available
GSK Investigational Site
Chelyabinsk, 454052
Russian FederationActive - Recruiting
GSK Investigational Site
Moscow, 121170
Russian FederationActive - Recruiting
GSK Investigational Site
Novosibirsk, 630099
Russian FederationActive - Recruiting
GSK Investigational Site
Samara, 443063
Russian FederationActive - Recruiting
GSK Investigational Site
Singapore, 529889
SingaporeSite Not Available
GSK Investigational Site
Durban, 4091
South AfricaSite Not Available
GSK Investigational Site
Johannesburg, 1830
South AfricaSite Not Available
GSK Investigational Site
Ansan-si Gyenggi-do, 15355
South KoreaSite Not Available
GSK Investigational Site
Busan, 47392
South KoreaSite Not Available
GSK Investigational Site
Pusan, 49241
South KoreaSite Not Available
GSK Investigational Site
Seoul, 05505
South KoreaSite Not Available
GSK Investigational Site
HebrOn, 08035
SpainSite Not Available
GSK Investigational Site
León, 24080
SpainSite Not Available
GSK Investigational Site
Madrid, 28031
SpainSite Not Available
GSK Investigational Site
Santander, 39008
SpainSite Not Available
GSK Investigational Site
Valencia, 46026
SpainSite Not Available
GSK Investigational Site
Vigo, 36071
SpainSite Not Available
GSK Investigational Site
Kaohsiung City, 807
TaiwanSite Not Available
GSK Investigational Site
Taichung, 40447
TaiwanSite Not Available
GSK Investigational Site
Tainan, 70403
TaiwanSite Not Available
GSK Investigational Site
Taipei, 10002
TaiwanSite Not Available
GSK Investigational Site
Taipei County, 104
TaiwanSite Not Available
GSK Investigational Site
Taoyuan, 333
TaiwanSite Not Available
GSK Investigational Site
Bangkok, 10330
ThailandSite Not Available
GSK Investigational Site
Chiang Mai, 50200
ThailandSite Not Available
GSK Investigational Site
Kho Hong Hat Yai, 90110
ThailandSite Not Available
GSK Investigational Site
Cottingham, HU16 5JQ
United KingdomSite Not Available
GSK Investigational Site
Liverpool, L7 8XP
United KingdomSite Not Available
GSK Investigational Site
London, WC1E 6JB
United KingdomSite Not Available
GSK Investigational Site
Plymouth, PL68DH
United KingdomSite 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
Colorado Springs, Colorado 80907
United StatesSite Not Available
GSK Investigational Site
Boston, Massachusetts 02114
United StatesSite Not Available
GSK Investigational Site
Detroit, Michigan 48202
United StatesSite Not Available

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