ALXN1850: ALXN1850 will be administered via subcutaneous (SC) injection.
asfotase alfa: Asfotase alfa will be administered via SC injection.
Study summary
The primary purpose of this study is to assess the safety and tolerability of ALXN1850 versus asfotase alfa in pediatric participants with HPP previously treated with asfotase alfa.
Eligibility
Sex
ALL
Min age
2 Years
Max age
11 Years
Healthy volunteers
No
Inclusion Criteria:
* 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. Note: participants currently treated with 9 mg/kg (eg, 3 mg/kg 3 times per week) will not be allowed in the study.
Exclusion Criteria:
* 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
Primary outcome measure(s)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) — Baseline Through Day 169
Trial sites (21)
Facility
City
Region
Status
Research Site
Hartford
Connecticut
Research Site
Baltimore
Maryland
Research Site
Minneapolis
Minnesota
Research Site
Kansas City
Missouri
Research Site
Durham
North Carolina
Research Site
Nashville
Tennessee
Research Site
Mar del Plata
Argentina
Research Site
South Brisbane
Australia
Research Site
Ottawa
Ontario
Research Site
Bunkyō City
Japan
Research Site
Minatoku
Japan
Research Site
Suita-shi
Japan
Research Site
Yonago-shi
Japan
Research Site
Altındağ
Turkey (Türkiye)
Research Site
Ankara
Turkey (Türkiye)
Research Site
Edirne
Turkey (Türkiye)
Research Site
Erzurum
Turkey (Türkiye)
Research Site
Istanbul
Turkey (Türkiye)
Research Site
Birmingham
United Kingdom
Research Site
Manchester
United Kingdom
Research Site
Sheffield
United Kingdom
More Alexion Pharmaceuticals, Inc. trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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