A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, ADD-ON TRIAL EVALUATING EFFICACY ANDSAFETY OF HYDROXYCHLOROQUINE IN EARLY SYSTEMIC SCLEROSIS (SSc)- HYDROXYSSc - HYDROXYSSc

Azienda Ospedaliero-Universitaria Policlinico Umberto I0 个研究点目标入组 151 人开始时间: 2024年7月10日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Diagnosis of SSc according 2013 ACR/EULAR criteria for classification of SSc (van den Hoogen et al, 2013)., Written Informed Consent (IC)(patient must be able and agree to sign an IC according ICH-GCP guidelines and local laws), Age >= 18 years, Disease duration <= 5 years from the first non-Raynaud’s symptom, Stable SSc standard treatment within 4 weeks prior to Screening visit, Subjects naïve to treatment with hydroxychloroquine or who have undergone a wash-out period of at least 16 weeks (approximately 3 half-lives of the drug)

•Known hypersensytivity to the study drug (active substance or excipients) or derivatives 4-aminoquinolines, Deficiency of glucose-6-phosphate dehydrogenase, Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1, Pregnant or breast feeding women, Other contraindicated clinical and / or laboratory conditions, Age < 18 years, Body weight < 45 kg, History of retynopathy and/or maculopathy, History of severe miopathy (other than SSc related), Anticoagulant and/or antiplatelet therapy, History of periferic neuropathy, History of hypoglycemia, History of bradycardia (HR<50) or ventricular arrhythmias

发起方

Azienda Ospedaliero-Universitaria Policlinico Umberto I