JPRN-jRCT2061220074招募中3 期
Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B Virus (B-Well 2) - B-Well 2
Okawa Yasutoshi0 个研究点目标入组 900 人开始时间: 2022年12月8日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants must be HBeAg negative at screening.
- •-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.
排除标准
- •-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.
研究者
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