A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 (PF-07265803) in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation

Array BioPharma Inc. (a wholly owned subsidiary of Pfizer Inc.)0 个研究点目标入组 160 人开始时间: 2018年5月28日最近更新: 2021年4月26日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 160

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

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:
•a. Gene positive for a pathogenic, likely pathogenic or VUS mutation in the LMNA gene as determined by an accredited clinical laboratory
•b. NYHA functional Class II or III that has been stable for at least 3 months
•c. Evidence of cardiac impairment as determined by LVEF= 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 intervention and defibrillation function activated at least 4 weeks prior to initiation of study intervention. Devices must have activated pacing capabilities or a separate pacemaker must be present.
•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
•Please refer to Protocol, section 5.1 for detailed list of Inclusion Criteria.
•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) or uncorrected, hemodynamically significant (i.e., moderate-severe) primary structural valvular disease not due to HR, per Investigator judgment.
•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.
•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) thyroid cancer or cervical cancer, or, with prior review by the Medical Monitor, other earlystage surgically curatively resected malignancies with less than a 20% expected 2-year recurrence rate.
•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.
•Please refer to Protocol, section 5.2 for detailed list of Exclusion Criteria.

研究者

发起方

Array BioPharma Inc. (a wholly owned subsidiary of Pfizer Inc.)

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