A Phase 3, Randomized, Open-label, Parallel-arm, Active-controlled, Multicenter Study to Evaluate Safety and Efficacy of ALXN1850 Versus Asfotase Alfa Administered Subcutaneously in Pediatric Participants (2 to < 12 years of age) with Hypophosphatasia (HPP) Previously Treated with Asfotase Alfa - CHESTNUT

Wuebbenhorst Hiroaki0 个研究点目标入组 4 人开始时间: 2023年11月19日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•1. Participant must be 2 or more and < 12 years of age at Day 1.
•2. Diagnosis of HPP documented in the medical records
•3. Presence of open growth plates by X-ray during Screening Period
•4. Tanner stage 2 or less during the Screening Period
•5. Must have been treated with 6 mg/kg/ week of asfotase alfa via SC injection administered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for more than 6 months before Day 1

•1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator.
•2. Diagnosis of primary or secondary hyperparathyroidism
•3. Hypoparathyroidism, unless secondary to HPP
•4. Any new fracture within 12 weeks before Day 1 (excluding pseudofractures)
•5. Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period
•6. History of allergy or hypersensitivity to any ingredient contained in asfotase alfa or ALXN1850
•7. Body weight < 10 kg during the Screening Period

发起方

Wuebbenhorst Hiroaki