jRCT2031260175暂停不适用
A Study to Evaluate the Efficacy and Safety of Concomitant Use of Eplontersen and ALXN2220 Compared With Eplontersen and Placebo for Adults Participants With ATTR-CM. (ATTRiumph)
未提供0 个研究点目标入组 20 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant must be >_ 18 years to <_ 85 years at the time of signing the informed consent.
- •Participants who have a diagnosis of ATTR-CM with either wild-type or variant TTR genotype based on 1 of the following:
- •Endomyocardial biopsy with confirmatory TTR amyloid typing OR
- •Grade 2 or 3 cardiac uptake on 99mTc scintigraphy in the absence of monoclonal gammopathy OR
- •Grade 2 or 3 cardiac uptake on 99mTc scintigraphy AND confirmatory TTR amyloid typing in the presence of monoclonal gammopathy.
- •NYHA Class I to III at Screening and life expectancy of >_ 1 year as per the Investigator's judgement.
- •End-diastolic IVST >_ 12 mm on echocardiography.
- •NT-proBNP >_ 600pg/mL for participants without ongoing atrial fibrillation/flutter at Screening or NT-proBNP >_ 1200pg/mL for participants with ongoing atrial fibrillation/flutter at Screening.
- •Able to complete symptom-limited maximal CPET at Screening based on the following test criteria:
- •Able to exercise to near exhaustion during CPET as exhibited by RER >_ 1.0 during symptom-limited CPET conducted during screening.
- •If participant does not achieve RER >_1.0, the CPET may be repeated once, at least 48 hours but less than 2 weeks (but before randomization) after the initial test.
- •Treated according to locally recognised guidelines on standard-of-care treatment for patients with HF.
- •Therapy should have been individually optimised and stable for >_ 4 weeks (except diuretics) and include, unless contraindicated or not tolerated, treatment of high BP (targeting SBP < 130 mmHg as suggested in 2022 American College of Cardiology/American Heart Association/Heart Failure Society of America HF guidelines), and ischaemic heart disease.
- •Willingness to adhere to daily self-administered vitamin A supplementation (3000 IU).
排除标准
- •Known leptomeningeal amyloidosis.
- •Known light chain (AL) or secondary (amyloid A) amyloidosis, or any other form of systemic amyloidosis.
- •Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy primarily due to hypertension, valvular heart disease, or ischaemic heart disease per Investigator's assessment.
- •Acute coronary syndrome, unstable angina, stroke, transient ischaemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 12 weeks of Screening.
- •Uncontrolled hypertension (average resting SBP > 160 mmHg or DBP > 100 mmHg at Screening).
- •Average resting SBP < 90 mmHg or symptomatic orthostatic hypotension, despite appropriate treatment, at Screening per Investigator's assessment.
- •Uncontrolled ventricular clinically significant cardiac arrhythmia, per Investigator's assessment.
- •Left ventricular ejection fraction < 30% on echocardiography measured locally at Screening.
- •Severe pulmonary impairment (SpO2 <_ 92%) defined as resting SpO2 below 92% on room air, measured by pulse oximetry, indicative of severe lung disease. Participants requiring supplemental oxygen to maintain SpO2 >_ 92%.
- •Participants with renal failure requiring dialysis.
- •History of solid organ transplantation or ventricular assist device or listing for heart transplantation at Screening. Note: prior history of planned corneal transplant is not an exclusion criterion.
- •Suspected or known intolerance/allergy to proteins or any components of the study intervention.
研究者
相似试验
招募中
不适用
Efficacy and Safety of Orforglipron in Participants With Peripheral Artery Disease (J2A-MC-GZPR)Peripheral Arterial DiseasejRCT20312505701,205
招募中
1 期
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants with Advanced Solid Malignancies2024-511453-22-00Kumquat Biosciences Inc.112
招募中
不适用
An Exploratory Study of novel diuretic therapy for cirrhotic ascitesLiver cirrhosis with uncontrolled ascites complicated by Type 2 diabetes mellitusjRCT103125078610
招募中
2 期
A study to evaluate the safety and efficacy of the tumor-targeting human antibody-cytokine fusion protein L19TNF plus lomustine in patients with glioblastoma at first progressionGlioblastoma2022-501822-39-00Philogen S.p.A.113
招募中
2 期
Evaluation of the safety and efficacy of Continuous Dopaminergic Stimulation by intracerebroventricular administration of anaerobically conserved dopamine in Parkinson's disease at the motor fluctuation stage: Single-center pilot studyParkinson's disease2024-517566-42-00Centre Hospitalier Universitaire De Lille, InBrain Pharma12