EUCTR2017-004310-25-NO进行中（未招募）1 期
A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Selected Key Inclusion Criteria:
- •Provide a signed and dated informed consent document prior to initiation of any study-related procedures. Patients under guardianship or partial guardianship will be eligible unless prohibited by local laws or by local/central ethic committees
- •Age = 18 years at time of informed consent
- •Patients with symptomatic lamin A/C protein (LMNA)-related cardiomyopathy Class II/III/ or Class IV defined as:
- •o Gene positive for a deleterious mutation in the LMNA gene as determined by the study central laboratory or by initial laboratory testing (central confirmation of initial laboratory results is required prior to randomization
- •o Evidence of cardiac impairment as determined by EF = 50%
- •Patient will have an implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D). ICD implanted at least 4 weeks prior to initiation of study treatment or CRT-D initiated at least 6 months prior to initiation of study treatment
- •Class II/III patients must have objective functional impairment evidenced by a reduction in 6-minute walk test (6MWT);
- •Stable medical and/or device therapy consistent with American Heart Association (AHA) / American College of Cardiology (ACC) or European Society of Cardiology (ESC) guidelines
- •Patients must meet acceptable hematology, hepatic and renal laboratory values as specified within 35 days prior Day 1
- •Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Selected Key Exclusion Criteria:
- •Presence of other form(s) of cardiomyopathy contributing to HF (e.g., inflammatory or infiltrative cardiomyopathy) or clinically significant cardiac anatomic abnormality (e.g., LV aneurysm).
- •Clinically significant coronary artery disease (e.g., coronary revascularization, exercise-induced angina) per Investigator judgment.
- •Uncorrected, hemodynamically significant (i.e., moderatesevere) primary structural valvular disease not due to HF.
- •Currently receiving or deemed at high risk of requiring chronic renal replacement therapy (e.g., hemodialysis or peritoneal dialysis) within 6 months.
- •Treatment with any investigational agent(s) for HF within 35 days prior to Day 1. Any treatment with an investigational agent(s) requires approval from the Medical Monitor.
- •Malignancy that is active or has been diagnosed within 3 years prior to screening, except surgically curatively resected in situ malignancies or surgically cured early breast cancer, prostate cancer, skin cancer (basal cell carcinoma, squamous cell carcinoma) or cervical cancer.
- •Non-cardiac condition that limits lifespan to < 1 year.
- •Serum positive for hepatitis B surface antigen, viremic hepatitis C, or human immunodeficiency virus (HIV) at screening.
- •Pregnancy or breastfeeding, or patients who plan to become pregnant during the duration of the trial
- •Patients with an underlying condition that may impact the ability of the 6MWT to reflect changes in cardiovascular function such as: an orthopedic condition that limits walking abilities (e.g., severe arthritis), significant musculoskeletal pathology, significant chronic obstructive pulmonary disease (COPD) that limits exercise tolerance or any other condition that according to the Investigator's assessment significantly limits a patient's performance on the 6MWT independently from the patient's cardiomyopathy.
- •Documented hypersensitivity/allergy or clinically significant intolerance to any component of drug product.
研究者
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