Last updated 16 days ago

Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

40 patients around the world

Available in Argentina, United States

Alexion Pharmaceuticals, Inc.

40Patients around the world

This study is for people with

Hypophosphatasia

To 11 Years

All Gender

: Diagnosis of HPP documented in the medical records
Presence of open growth plates by X-ray during Screening Period
Tanner stage 2 or less during the Screening Period
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 ≥ 6 months before Day 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.
Diagnosis of primary or secondary hyperparathyroidism
Hypoparathyroidism, unless secondary to HPP
Any new fracture within 12 weeks before Day 1 (excluding pseudofractures)
Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period
History of allergy or hypersensitivity to any ingredient contained in asfotase alfa or ALXN1850
Body weight < 10 kg during the Screening Period

StudyCHESTNUT

SponsorAlexion Pharmaceuticals, Inc.

Conditions

Requirements

To 11 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06079372