Lon-term study of idursulfase beta in patients with mucopolysaccharidosis type II
Lon-term study of idursulfase beta in patients with mucopolysaccharidosis type II - CKK001
Mucopolysaccharidosis type II;D016532
[Investigative drug, dose, and administration method] - Investigative drug: Vial formulation filled with idursulfase beta for intracerebroventricular administration (Concentration 15 +/- 1.5 mg/mL, liquid volume 1.25 mL) - Dose and administration method: An implantable cerebrospinal fluid reservoir is attached to the subject's head, and idursulfase beta 30 mg is administered to the ventricles once every 4 weeks. [Investigative drug, dose, and administration method] - Investigative drug: Vial formulation filled w ...
Study of Idursulfase-beta (GC1111) in Hunter Syndrome
Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Idursulfase-beta (GC1111) in Hunter Syndrome (Mucopolysaccharidosis II) Patients Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging Study to Evaluate the Pharmacokin ...
Phase I/II clinical trial of idursulfase beta for mucopolysaccharidosis type II
Phase I/II clinical trial of idursulfase beta for mucopolysaccharidosis type II
Patients at the age between 6 months and 15 years with severe type mucopolysaccharidosis type II intravenously administered isursulfase at least for 24 weeks Patients at the age between 6 months and 15 years with severe type mucopolysaccharidosis type II int ...
Intervention type:DRUG. Intervention1:BHP001, Dose form:INJECTION, Route of administration:OTHER.
To Evaluate the Safety and Efficacy of Hunterase(Idursulfase-beta) in Hunter Syndrome Patients < 6 Years of Age Receiving Idursulfase Enzyme Replacement Therapy To Evaluate the Safety and Efficacy of Hunterase(Idursulfase-beta) in Hunter Syndrome Patients < 6 Y ...