2024-519282-22-00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 Not Virologically Suppressed with Bulevirtide (ECLIPSE 2)
Vir Biotechnology Inc.35 个研究点 分布在 6 个国家目标入组 132 人开始时间: 2025年5月26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
- 132
- 试验地点
- 35
- 主要终点
- Part I: HDV RNA < LLOQ, TND at Week 24
研究概览
简要总结
Part I: To evaluate the antiviral efficacy of tobevibart+elebsiran in participants with BLV treatment experience Part 2: To evaluate the efficacy of tobevibart+elebsiran in achieving SVR in participants who systematically interrupt treatment
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
- 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
- •HDV RNA ≥ 500 IU/mL at screening
- •Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1
- •Noncirrhotic or compensated cirrhotic liver disease at screening
- •Body mass index (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 < 10 IU/mL at screening, and currently on locally approved NRTI therapy. Participants must be on one of the following NRTI therapies starting at Day 1: tenofovir alafenamide (taken alone or as part of a fixed-dose combination therapy), tenofovir disoproxil fumarate (taken alone or as part of a fixed-dose combination therapy), or entecavir
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 decompensationd. 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 (ie, 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 >200 copies/mL or CD4+ T-cell counts < 500/mm3 is within the last 12 months) or any HIV-2 infection.
- •Participants with HAV (participants who are HAV IgM positive can be enrolled if asymptomatic and HAV IgG positive).
- •Participants with HEV (participants who are HEV IgM positive can be enrolled if asymptomatic and HEV IgG positive). In cases where acute infection status cannot be determined by serologies a serum or stool HEV RT-PCR can be obtained. The participant is ineligible if PCR is positive
- •Current therapy or therapy within 24 weeks of of first study intervention administration with an immunomodulatory agent (eg, IFN-α), immune checkpoint inhibitors, immunosuppressants (eg, diseasemodifying antirheumatic drugs), cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids (equivalent of 10mg prednisone QD).
结局指标
主要结局
Part I: HDV RNA < LLOQ, TND at Week 24
Part I: HDV RNA < LLOQ, TND at Week 24
Part 2: HDV RNA < LLOQ, TND 24 weeks after end of treatment
Part 2: HDV RNA < LLOQ, TND 24 weeks after end of treatment
次要结局
- Part I: HDV RNA < LLOQ, TND at Week 48 and Week 96 Change from baseline in HDV RNA at Week 48 and Week 96
- Part I: Change from baseline in ALT at Week 24, Week 48 and Week 96
- Part I: Incidence of TEAEs and SAEs through Week 24, Week 48 and Week 96
- Part I: • Incidence of decompensated cirrhosis (clinical event or CPT score ≥ 7) through Week 48 and Week 96 • Incidence of HCC or progression to liver failure requiring transplantation or resulting in death through Week 48 and Week 96
- Part I: Change from baseline in liver stiffness as measured by liver elastography at Week 48 and Week 96
- Part I: • Change from baseline in HBsAg at Week 24, Week 48 and Week 96 • Categorical summary of HBsAg at Week 24, Week 48 and Week 96
- Part I: • ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 24, Week 48 and Week 96 • ALT ≤ ULN at Week 24, Week 48 and Week 96
- Part II: • HDV RNA < LLOQ, TND at 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
- Part II: • HDV RNA < LLOQ, TND at Week 120, Week 144, Week 192 and Week 240 • Change from baseline in HDV RNA at Week 120, Week 144, Week 192 and Week 240
- Part II: • Change from baseline in ALT from tobevibart+elebsiran interruption at Week 96 to Week 120, Week 144, Week 192 and Week 240
- Part II: 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.
- Part II: • Incidence of decompensation through Week 144, Week 192 and Week 240 • Incidence of HCC or progression to liver failure requiring transplantation or resulting in death through Week 144, Week 192 and Week 240
- Part II: Change from baseline in liver stiffness as measured by liver elastography at Week 144, Week 192 and Week 240
- Part II: Categorical summary of HBsAg at Week 120, Week 144, Week 192 and Week 240
- Part II: TEAEs, SAEs through Week 120, Week 144, Week 192 and Week 240
- Part II: • ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 120, Week 144, Week 192 and Week 240 • ALT ≤ ULN at Week 120, Week 144, Week 192 and Week 240
- Part II: ALT ≤ ULN and HDV RNA < LLOQ, TND at Week 120, Week 144, Week 192 and Week 240 • ALT ≤ ULN at Week 120, Week 144, Week 192 and Week 240
研究者
Leah Gaffney
Scientific
Vir Biotechnology Inc.
研究点 (35)
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