Phase 3 Study of Bepirovirsen in Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B (B-Well 1)

JRCT ID: jRCT2071220078

Registered date:08/12/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Chronic Hepatitis B
• Date of first enrollment: 11/01/2023
• Target sample size: 900
• Countries of recruitment: Argentina,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,France,Japan,Germany,Japan,Greece,Japan,Hong Kong,Japan,Hungary,Japan,India,Japan,Italy,Japan,Mexico,Japan,Panama,Japan,Poland,Japan,Romania,Japan,Singapore,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Thailand,Japan,Turkey,Japan,UK,Japan,US,Japan,Malaysia,Japan,Vietnam,Japan
• Study type: Interventional

Intervention(s)

-Bepirovirsen
-Placebo

Outcome(s)

• Primary Outcome: Number of participants achieving functional cure (FC) with baseline HBsAg <-1000 IU/mL

Secondary Outcome

-Number of participants achieving FC with baseline HBsAg <-3000 IU/mL
-Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg <-1000 IU/mL
-Number of participants achieving sustained suppression of HBV DNA (<LLOQ) with baseline HBsAg <-3000 IU/mL

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Participants who have documented chronic HBV infection >-6 months prior to Screening and currently receiving stable NA therapy defined as no changes to their NA regimen from at least 6 months prior to Screening and with no planned changes to the stable regimen 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 as plasma or serum HBV DNA <90 IU/mL.
-Alanine aminotransferase (ALT) <-2 X upper limit of normal (ULN).
-Participants who are willing and able to cease their NA treatment in accordance with the protocol.

Exclude 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 vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause) or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
-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) or topical/inhaled steroid use.
-Participants to whom immunosuppressive treatment, including therapeutic doses of steroids is contraindicated, should not be considered for enrolment in the study.
-Currently taking, or has taken within 12 months of Screening, any interferon-containing therapy.
-Participants requiring anti-coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of the study, by the discretion of the investigator. Occasional use is permitted.
-Prior treatment with any oligonucleotide or siRNA within 12 months prior to the first dosing day.
-Prior treatment with bepirovirsen.

Related Information

• Primary Sponsor: Okawa Yasutoshi
• Secondary ID(s): NCT05630807