A Multicenter, Open-label Study to Evaluate the Safety and Diagnostic Efficacy of Mangoral in Patients With Known or Suspected Focal Liver Lesions and Severe Renal Impairment
Status: Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 16 Nov 2019
Price : $35 *
At a glance
- Drugs CMC 001 (Primary) ; Alanine; Colecalciferol; Manganese chloride
- Indications Liver disorders; Renal impairment
- Focus Diagnostic use; Registrational
- Acronyms SPARKLE
- Sponsors Ascelia Pharma
- 07 Oct 2019 Status changed from planning to not yet recruiting.
- 22 Aug 2019 According to an Ascelia Pharma media release, the company have now fully financed this study.The company has received supportive feedback from EMA on the Phase III program for Mangoral.
- 07 May 2019 According to an Ascelia Pharma media release, the company has completed discussions with the European Medicines Agency (EMA) regarding this study.