A phase 2 multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic sclerosis or systemic sclerosis-associated pulmonary arterial hypertension.

Cumberland Pharma Inc0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Diffuse Cutaneous SSc Inclusion Criterion
•1.Adults fulfilling the 2013 ACR/EULAR classification criteria for SSc with diffuse cutaneous SSc within 7 years following initial diagnosis as defined by onset of the first non-Raynaud symptom .
•SSc-PAH Inclusion Criteria
•1.Adults fulfilling the 2013 ACR/EULAR classification criteria for SSc with confirmed SSc-PAH (confirmed via previous cardiac catheterization)
•2.Stable oral therapy for PAH for at least 30 days (monotherapy or any combination)
•3.NYHA Class I-III Heart Failure.

•1.Have a diagnosis of systemic sclerosis sine scleroderma;
•2.Be less than 18 years of age or greater than or equal to 80 years of age;
•3.Be pregnant, nursing, or planning to become pregnant;
•4.Current or planned treatment with prostanoid therapy;
•5.Current or planned treatment with rituximab or pirfenidone;
•6.Current or planned corticosteroid therapy greater than 15mg per day of prednisone or prednisone equivalent;
•7.Significant lung disease, defined as FVC < 50% predicted or DLCO <40% predicted;
•8.Significant kidney disease, defined as Glomerular Filtration Rate [GFR] < 60 ml/min;
•9.Have moderate or severe hepatic impairment;
•10.Contraindication to MRI (e.g., implanted magnetic material, claustrophobia);
•11.Known hypersensitivity to gadolinium;
•12.Any cause of pulmonary hypertension other than WHO Group I associated with SSc;
•13.Use of aspirin > 81 mg per day in the last two weeks;
•14.Use of warfarin, heparin or other anticoagulants in the last 30 days;
•15.Recent (within 6 weeks) myocardial infarction or persistent atrial arrhythmias;
•16.Have a history of allergy or hypersensitivity to ifetroban;
•17.Have taken investigational drugs within 30 days before Investigational Medicinal Product (IMP) administration;
•18.Inability to understand the requirements of the study and abide by the study restrictions and to return for the required treatments and assessments;
•19.Be otherwise unsuitable for the study, in the opinion of the investigator.

发起方

Cumberland Pharma Inc