Detail of the clinical trial

Title of the trial An Open-label Extension of Study HGT-MLD-070 Evaluating Long Term Safety and Efficacy of Intrathecal Administration of HGT-1110 in Patients with Metachromatic Leukodystrophy
EudraCT number 2012-003775-20
Protocol number HGT-MLD-071
Sponsor Shire Human Genetics Therapies Inc,300 Shire Way,Lexington,MA 02421, United States of America
Indications Neurology
Diagnosis metachromatic leukodystrophy
Population in clinical trial Infants and Toddlers (28 days - 23 months)
Children (2-11 years)
Year of receiving the request to Institute (SÚKL) 2014
Date of approval by Institute (SÚKL) 6.6.2014, prodl. 17.4.2015
Date of approval by EC 12.2.2014
Date of initiation CT in ČR 27.8.2015
Date of ending CT in ČR
Sites Nemocnice Sv. Anny v Brně,Odděleni neurologie,Pekařská 53,Brno,656 91

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