NCT07454837招募中2 期
A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 44
- 主要终点
- Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])
研究概览
简要总结
This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).
详细描述
This is a Phase 2b/3, open-label, multicenter study evaluating the efficacy and safety of switching participants on bulevirtide to brelovitug for the treatment of chronic hepatitis delta (CHD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent.
- •Male or female, ≥18 years of age at Screening.
- •Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.
- •Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.
- •HDV RNA ≥100 IU/mL at Screening.
排除标准
- •Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding).
- •Known history of immune-complex disease.
- •Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- •Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis).
- •History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.
研究组 & 干预措施
Delayed Switch from Bulevirtide to Brelovitug
Experimental
Participants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks.
干预措施: Bulevirtide (Drug)
Immediate Switch to Brelovitug
Experimental
Participants will switch to brelovitug 300 mg once weekly for 96 weeks.
干预措施: Brelovitug (BJT-778) (Drug)
结局指标
主要结局
Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])
时间窗: Week 24
The proportion of participants with undetectable HDV RNA (\<LLOQ, TND) at Week 24
次要结局
- Change from baseline in liver stiffness(Up to Week 96)
- Change from baseline in CTP score(Up to Week 96)
- Change from baseline in MELD score(Up to Week 96)
- Proportion of participants with clinical disease progression from baseline(Up to Week 96)
- Change from baseline in APRI(Up to Week 96)
- Proportion of participants achieving HDV RNA (HDV RNA < LLOQ, TND) at Weeks 48, 72, and 96.(Up to Week 96)
- Proportion of participants achieving normal ALT with HDV RNA (HDV RNA < LLOQ, TND) at Weeks 24, 48, 72 and 96(Up to Week 96)
- Change in baseline in CTP score(Up to Week 96)
- Proportion of participants achieving normal ALT at Weeks 24, 48, 72 and 96.(Up to Week 96)
- Incidence and severity of treatment-emergent adverse events (TEAEs)(Up to Week 96)
- Proportion of participants who permanently discontinue treatment due to an adverse event(Up to Week 96)
- Change from baseline in serum total bile salts(Up to Week 96)
- Proportion of participants achieving virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)(Up to Week 96)
- Proportion of participants achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96.(Up to Week 96)
- Proportion of participants achieving undetectable HDV RNA (HDV RNA < LLOQ, TND) at Weeks 48, 72, and 96.(Up to Week 96)
- Proportion of participants achieving normal ALT with virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)(Up to Week 96)
- Proportion of participants achieving normal ALT with HDV RDA < LLOQ at Weeks 24, 48, 72 and 96.(Up to Week 96)
- 11. Proportion of participants achieving normal ALT with undetectable HDV RNA (HDV RNA < LLOQ, TND) at Weeks 24, 48, 72 and 96(Up to Week 96)
- Change from baseline in HDV RNA(Up to Week 96)
- Change from baseline in ALT levels(Up to Week 96)
- Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up(Up to Week 48)
研究者
研究点 (44)
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