Phase
Condition
N/ATreatment
asfotase alfa
ALXN1850
Clinical Study ID
Ages 2-11 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 injectionadministered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for ≥ 6months 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
Exclusion Criteria:
History or presence of cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrinological, hematological, neurological disorders, or anyother disorders that are capable of significantly altering the absorption,metabolism, or elimination of drugs; constituting a risk when taking the studyintervention; or interfering with the interpretation of data as determined by theInvestigator.
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 (inthe opinion of the Investigator) during the Randomized Evaluation Period
History of allergy or hypersensitivity to any ingredient contained in asfotase alfaor ALXN1850
Body weight < 10 kg during the Screening Period
Study Design
Connect with a study center
Research Site
Buenos Aires, C1425BPE
ArgentinaSite Not Available
Research Site
Córdoba, 5000
ArgentinaSite Not Available
Research Site
Mar del Plata, B7600
ArgentinaSite Not Available
Research Site
South Brisbane, 4101
AustraliaSite Not Available
Research Site
Westmead, 2145
AustraliaSite Not Available
Research Site
Winnepeg, Manitoba R3E 3P4
CanadaSite Not Available
Research Site
Ottawa, Ontario K1H 8L1
CanadaSite Not Available
Research Site
Le Kremlin Bicêtre, 94270
FranceSite Not Available
Research Site
Paris, 75015
FranceSite Not Available
Research Site
Homburg, 66421
GermanySite Not Available
Research Site
Würzburg, 97074
GermanySite Not Available
Research Site
Bangalore, 560017
IndiaSite Not Available
Research Site
Genova, 16147
ItalySite Not Available
Research Site
Milano, 20133
ItalySite Not Available
Research Site
Roma, 00190
ItalySite Not Available
Research Site
Bunkyo-ku, 113-8431
JapanSite Not Available
Research Site
Kyoto-shi, 606-8507
JapanSite Not Available
Research Site
Minato-ku, 105-8471
JapanSite Not Available
Research Site
Suita-shi, 565-0871
JapanSite Not Available
Research Site
Yonago-shi, 683-8504
JapanSite Not Available
Research Site
Altındağ, 06230
TurkeySite Not Available
Research Site
Altındağ-Ankara, 06230
TurkeySite Not Available
Research Site
Ankara, 06560
TurkeySite Not Available
Research Site
Bursa, 16059
TurkeySite Not Available
Research Site
Edirne, 22030
TurkeySite Not Available
Research Site
Erzurum, 25240
TurkeySite Not Available
Research Site
Istambul, 34899
TurkeySite Not Available
Research Site
Istanbul, 34020
TurkeySite Not Available
Research Site
Küçükçekmece, 34295
TurkeySite Not Available
Research Site
Birmingham, B4 6NH
United KingdomSite Not Available
Research Site
Manchester,
United KingdomSite Not Available
Research Site
Sheffield, S10 2TH
United KingdomSite Not Available
Research Site
Hartford, Connecticut 06106
United StatesSite Not Available
Research Site
Baltimore, Maryland 21287
United StatesSite Not Available
Research Site
Boston, Massachusetts 02115
United StatesSite Not Available
Research Site
Minneapolis, Minnesota 55455
United StatesSite Not Available
Research Site
Kansas City, Missouri 64108
United StatesSite Not Available
Research Site
Saint Louis, Missouri 63110
United StatesSite Not Available
Research Site
Durham, North Carolina 27705
United StatesSite Not Available
Research Site
Nashville, Tennessee 37212
United StatesSite Not Available
Research Site
Charlottesville, Virginia 22908
United StatesSite Not Available
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