2024-520062-54-00招募中2 期
A Phase 2b Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy versus Bulevirtide in Participants with Chronic HDV Infection (ECLIPSE 3)
Vir Biotechnology Inc.34 个研究点 分布在 8 个国家目标入组 53 人开始时间: 2025年6月11日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 34
- 主要终点
- HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) at Week 48 (Part 1)
研究概览
简要总结
(Primary Objective 1) To evaluate the antiviral efficacy of tobevibart+elebsiran vs BLV (bulevirtide) in participants with chronic HDV infection (Part 1)
(Primary Objective 2) To evaluate the efficacy of tobevibart+elebsiran in achieving SVR (sustained virologic response) in participants who systematically interrupt treatment per protocol (Part 2)
(Primary Objective 3) To evaluate the safety of tobevibart+elebsiran and BLV in participants with chronic HDV infection (Primary Safety)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adult men and women aged ≥ 18 years (or age of legal consent, whichever is older) to ≤ 70 years at the time of signing informed consent
- •Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening.
- •Noncirrhotic or compensated cirrhotic liver disease at screening
- •BMI ≥ 18 kg/m2 to ≤ 40 kg/m2
- •On NRTI therapy against HBV for at least 12 weeks prior to Day 1 or have HBV DNA < 20 IU/ml at screening, and currently on locally approved NRTI therapy. Participants must be on one of the following NRTI therapies: tenofovir alafenamide (taken alone or as part of fixed-dose combination therapy), tenofovir disoproxil fumarate (taken alone or as part of fixed-dose combination therapy), or entecavir.
- •Note: Other protocol defined Inclusion criteria may apply
排除标准
- •Current or prior history of any of the following: a. Clinically significant laboratory abnormalities, co-morbid medical condition (other than HBV/HDV coinfection) or planned medical procedure that may interfere with the participant’s treatment, assessment, or compliance with the protocol. b. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. c. Current or previous (within 24 months of screening) clinically identified hepatic decompensation d. Bone marrow, peripheral blood stem-cell or solid organ transplantation e. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. f. Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; ductal carcinoma in situ and cervical carcinoma in situ is allowed if appropriately treated prior to screening); participants under evaluation for malignancy are not eligible. g. Significant drug allergy (such as anaphylaxis or hepatotoxicity)
- •One or more additional known primary or secondary causes of liver disease, other than hepatitis B or hepatitis D (i.e., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, Wilson’s disease, other congenital or metabolic condition affecting the liver, congestive heart failure, etc).
- •History of clinically significant immune complex disease as determined by the Investigator.
- •History of anaphylaxis, allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites or excipients
- •Participants with active HCV (participants with HCV antibodies can be enrolled if screening HCV RNA PCR test is negative).
- •Participants with HIV infection can be enrolled if CD4+ T-cell counts are > 500/mm3 and HIV RNA PCR is below the limit of detection for at least 12 months
- •Any previous treatment with bulevirtide (BLV).
- •ALT ≥ 5 × ULN
- •Note: Other protocol defined Exclusion criteria may apply
结局指标
主要结局
HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) at Week 48 (Part 1)
HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) at Week 48 (Part 1)
Part 2: HDV RNA < LLOQ, TND 24 weeks after end of treatment interruption (Week 120)
Part 2: HDV RNA < LLOQ, TND 24 weeks after end of treatment interruption (Week 120)
Primary safety – Incidence of TEAEs and SAEs through Week 48
Primary safety – Incidence of TEAEs and SAEs through Week 48
次要结局
- • HDV RNA < LLOQ at Week 48 • Change from baseline in HDV RNA at Week 48
- Change from baseline in ALT at Week 48
- Change from baseline in liver stiffness as measured by liver elastography at Week 48
- • Incidence of decompensated cirrhosis (clinical event or CPT score ≥ 7) by Week 48 • Incidence of HCC and progression to liver failure requiring transplantation or resulting in death by Week 48
- • Change from baseline in HBsAg at Week 48 • Categorical summary of HBsAg at Week 48
- • HDV RNA < LLOQ, TND at Week 96, Week 120, Week 144, Week 192 and Week 240 • HDV RNA < LLOQ at Week 96, Week 120, Week 144, Week 192 and Week 240 • Change from baseline in HDV RNA at Week 96, Week 120, Week 144, Week 192 and Week 240 • Change from baseline in HDV RNA from tobevibart+elebsiran interruption at Week 96 to Week 120, Week 144, Week 192 and Week 240
- •Change from baseline in ALT at Week 96, Week 120, Week 144, Week 192 and Week 240 • Change from baseline in ALT from tobevibart+elebsiran interruption at Week 96 to Week 120, Week 144, Week 192 and Week 240
- • Change from baseline in liver stiffness as measured by liver elastography at Week 96, Week 120, Week 144, Week 192 and Week 240
- • Incidence of decompensated cirrhosis (clinical event or CPT score ≥ 7) by Week 96, Week 120, Week 144, Week 192 and Week 240 • Incidence of HCC and progression to liver failure requiring transplantation or resulting in death by Week 96, Week 120, Week 144, Week 192 and Week 240
- • Categorical summary of HBsAg at Week 96, Week 120, Week 144, Week 192 and Week 240 • Change from baseline in HBsAg at Week 96, Week 120, Week 144, Week 192 and Week 240
- • Incidence of TEAEs and SAEs through Week 96, Week 120, Week 144, Week 192 and Week 240 (secondary safety)
- • Incidence of AEs, SAEs and lab abnormalities from time of tobevibart+elebsiran interruption (Week 96) through Week 120, Week 144, Week 192 and Week 240 (secondary safety)
研究者
Carey Hwang
Scientific
Vir Biotechnology Inc.
研究点 (34)
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