NCT05276297 - A Study on the Safety, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide Against Chronic Hepatitis B (CHB) and Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy | Biotech Hunter

Enrollment

174

Participants

Timeline

Start Date

March 22, 2022

Primary Completion Date

August 5, 2025

Study Completion Date

August 5, 2025

Conditions

Hepatitis B, Chronic

Interventions

DRUG

GSK3228836

2 doses of GSK3228836 study intervention administered subcutaneously once per week for 12 weeks (Day 1 up to Day 78) to participants in ASO12-TI and ASO12 groups, or for 24 weeks (Day 1 up to Day 162) to participants in ASO24-TI and ASO24 groups, plus loading doses administered at Day 4 and Day 11 (2 doses each day) to participants in all groups during Treatment 1 period.

BIOLOGICAL

GSK3528869A

"The GSK3528869A chronic Hepatitis B targeted immunotherapy (CHB-TI) consisting of 4 doses administered intramuscularly as follows:~* 1 dose of the Chimpanzee adenovectored HBV vaccine (ChAd155-hIi-HBV) at Day 1 of Treatment 2 period.~* 1 dose of the Modified Vaccinia Virus Ankara HBV vaccine (MVA-HBV) at Day 57 of Treatment 2 period.~* 2 subsequent doses of the AS01B-4-adjuvanted HBc-HBs proteins (HBc-HBs/AS01B-4) administered at Day 113 and Day 169 of Treatment 2 period."

DRUG

Control

4 doses of non-active control administered intramuscularly in the deltoid region of the non-dominant arm at Days 1, 57, 113 and 169 to participants in ASO24 and ASO12 control groups during Treatment 2 period.

Trial Locations (51)

333

GSK Investigational Site, Linkou - Taoyuan Hsien

404

GSK Investigational Site, Taichung

600

GSK Investigational Site, Chiayi City

704

GSK Investigational Site, Tainan City

807

GSK Investigational Site, Kaohsiung City

1229

GSK Investigational Site, Makati City

1407

GSK Investigational Site, Sofia

1431

GSK Investigational Site, Sofia

1605

GSK Investigational Site, Pasig

1784

GSK Investigational Site, Sofia

1797

GSK Investigational Site, Sofia

2650

GSK Investigational Site, Edegem

3000

GSK Investigational Site, Vratsa

5000

GSK Investigational Site, Veliko Tarnovo

6690

GSK Investigational Site, Istanbul

8800

GSK Investigational Site, Sliven

10330

GSK Investigational Site, Bangkok

10787

GSK Investigational Site, Berlin

20089

GSK Investigational Site, Rozzano MI

20122

GSK Investigational Site, Milan