2024-515919-22-00招募中3 期
A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants with Chronic HDV Infection (ECLIPSE 1)
Vir Biotechnology Inc.13 个研究点 分布在 3 个国家目标入组 11 人开始时间: 2025年5月12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
- 11
- 试验地点
- 13
- 主要终点
- HDV RNA < LLOQ (lower limit of quantification), TND (target not detected) and ALT (alanine aminotransferase) normalization (ALT ≤ ULN) at Week 48 for Arm 1 vs at Week 12 for Arm 2.
研究概览
简要总结
To evaluate the efficacy of tobevibart + elebsiran compared with delayed treatment in participants with chronic HDV infection To evaluate the safety of tobevibart + elebsiran in participants with chronic HDV infection
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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
- •Serum alanine aminotransferase (ALT) > ULN and < 5 x ULN
- •Body mass index (BMI) ≥ 18 kg/m2 to ≤ 40 kg/m2
- •On NRTI (nucleos(t)ide reverse transcriptase inhibitor) therapy against HBV for at least 12 weeks prior to Day 1 or have HBV DNA < 10 IU/ml at screening, and currently on one of the following NRTI therapies starting at day 1: tenofovir alafenamide, tenofovir disoproxil fumarate, 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, study drug component (ex. Oligonucleotide and/or GalNAc) 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 uncontrolled HIV-1 infection (defined as HIV-1 RNA PCR value above the lower limit of assay detection with CD4+ T-cell counts < 500/mm3 within the last 12 months) or any HIV-2 infection
- •Note: Other protocol defined Exclusion criteria may apply
结局指标
主要结局
HDV RNA < LLOQ (lower limit of quantification), TND (target not detected) and ALT (alanine aminotransferase) normalization (ALT ≤ ULN) at Week 48 for Arm 1 vs at Week 12 for Arm 2.
HDV RNA < LLOQ (lower limit of quantification), TND (target not detected) and ALT (alanine aminotransferase) normalization (ALT ≤ ULN) at Week 48 for Arm 1 vs at Week 12 for Arm 2.
Primary safety Incidence of TEAEs and SAEs through Week 12.
Primary safety Incidence of TEAEs and SAEs through Week 12.
次要结局
- • HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs at Week 12 for Arm 2 (key secondary endpoint). • HDV RNA < LLOQ at Week 48 for Arm 1 vs at Week 12 for Arm 2. • Change from baseline in HDV RNA at Week 48 for Arm 1 vs at Week 12 for Arm 2
- • ALT ≤ ULN at Week 48 for Arm 1 vs at Week 12 for Arm 2 • ALT < 1.25 × ULN at Week 48 for Arm 1 vs at Week 12 for Arm 2 • Change from baseline in ALT at Week 48 for Arm 1 vs at Week 12 for Arm 2
- • HDV RNA < LLOQ, TND and ALT < 1.25 × ULN at Week 48 for Arm 1 vs at Week 12 for Arm 2
- • HDV RNA < LLOQ, TND and ALT ≤ ULN at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • HDV RNA < LLOQ and ALT ≤ ULN at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • HDV RNA < LLOQ, TND and ALT < 1.25 × ULN at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment
- • HDV RNA < LLOQ, TND at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • HDV RNA < LLOQ at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • Change from baseline in HDV RNA at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment
- • ALT ≤ ULN at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • ALT < 1.25 × ULN at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment • Change from baseline in ALT at 48, 96, 144, 192 and 240 weeks of tobevibart + elebsiran treatment
- Change from baseline in liver stiffness as measured by liver elastography at 48, 96,144, 192 and 240 weeks of tobevibart + elebsiran treatment
- • Incidence of decompensated cirrhosis (clinical event or CPT score ≥ 7) by 48, 96, 144, 192and 240 weeks of tobevibart + elebsiran treatment • Incidence of HCC and progression to liver failure requiring transplantation or resulting in death by 48, 96. 144, 192 and 240 weeks of tobevibart + elebsiran treatment.
- Secondary safety: Incidence of TEAEs and SAEs through 48, 96, 144, 192and 240 weeks of treatment
研究者
Michael Chattergoon
Scientific
Vir Biotechnology Inc.
研究点 (13)
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