Chronic Hepatitis B Virus Infection
Conditions
Interventions
daplusiran/tomligisiran
placebo
Bepirovirsen
Sponsors
Ogawa Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -At least 18 years of age at the time of signing the informed consent. -Documented chronic HBV infection >=6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen from at least 6 months prior to Screening and with no planned changes to their stable regimen over the 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 as plasma 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 with the protocol. -Male and Female
Exclusion criteria
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 coagulopathy) or clinically significant physical examination findings. -Coinfection with Hepatitis C (cured =450 millisecond (msec) (if single electrocardiogram [ECG] at screening shows QTcF >=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion). -History of/sensitivity to bepirovirsen, DAP/TOM or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation -Participants who do not wish to discontinue taking NA therapy for their chronic HBV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of participants achieving functional cure after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment) . | — |
Secondary
| Measure | Time frame |
|---|---|
| -The number of participants achieving functional cure with high Baseline HBsAg level after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment). -The number of participants achieving functional cure with low Baseline HBsAg level after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment). -The number of participants achieving functional cure with low Baseline HBsAg level after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment) compared against placebo + bepirovirsen arm. -The number of participants with undetected HBsAg and HBV DNA <LLOQ at the end of bepirovirsen treatment. | — |
Countries
Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Italy, Japan, New Zealand, Singapore, South Africa, South Korea, Spain, Taiwan, UK, US
Contacts
Public ContactMasayuki Ogawa
GlaxoSmithKline K.K.
Outcome results
None listed