Sanofi Genzyme announced the start of their phase 4 study (B-CLEAR1, LPS15918), an open-label, multicenter, multinational, randomized, controlled, prospective clinical trial. The primary objective is to assess the reduction of plasma lyso-GL-3 in each group 12 months after randomization. The secondary objectives are to assess the reduction of kidney podocyte GL-3 and endothelial skin cells GL-3 contents, change in renal function and improvement of symptoms of Fabry disease using Fabry disease patient and clinician reported outcomes.
Male patients with classic Fabry disease 16-45 years of age may be considered for screening and participation.
To date, active sites comprise Czech Republic and Norway. Anticipated additional participating sites will include Denmark, France, Italy, Portugal, Turkey and the UK. A complete list of eligibility requirements can be found at www.clinicaltrialsregister.eu (Eudra CT Number: 2019-000064-21) or https://clinicaltrials.gov (NCT Number: 04143958).