Phase
Condition
N/ATreatment
ALXN1850
Placebo
Clinical Study ID
Ages 2-11 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of HPP documented in the medical records, and the following criteriafulfilled without other probable cause than HPP:
Presence of HPP-related rickets on skeletal X-rays during the Screening Period,with a minimum Rickets Severity Score (RSS) of 1.0 AND
Serum ALP activity below the age- and sex-adjusted normal range during theScreening Period as measured by the Central Laboratory OR 2 documented serumALP activity results, at least 15 days apart, below the age- and sex-adjustedlocal laboratory normal range during the 24 months before the Day 1 Visit.Note: Local laboratories need to be Clinical Laboratory Improvement Amendments (CLIA) or ISO 15189 certified, or have other local equivalent laboratorycertification with Alexion's approval.
- Must meet 1 of the following criteria:
Documented ALPL gene variant (pathogenic, likely pathogenic, or variant ofunknown significance) from a CLIA certified laboratory (Section 8.7)
Plasma PLP above the upper limit of normal (ULN) during the Screening Period (central or local laboratory results allowed per local regulations)
- Tanner stage 2 or less during the Screening Period
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 ALXN1850 orthe placebo comparator
Study Design
Connect with a study center
Research Site
Buenos Aires, C1199
ArgentinaSite Not Available
Research Site
Ciudad Autónoma de Buenos Aires, C1199
ArgentinaSite Not Available
Research Site
Ciudad de Buenos Aires, C1199
ArgentinaSite Not Available
Research Site
Mar del Plata, B7600FYK
ArgentinaSite Not Available
Research Site
Nedlands, 6009
AustraliaSite Not Available
Research Site
Nedlands 2064874, 6009
AustraliaSite Not Available
Research Site
Parkville, 3052
AustraliaSite Not Available
Research Site
Parkville 2153770, 3052
AustraliaSite Not Available
Research Site
Westmead, 2145
AustraliaSite Not Available
Research Site
Brussel, 1020
BelgiumSite Not Available
Research Site
Brussels, 1020
BelgiumSite Not Available
Research Site
Brussels 2800866, 1020
BelgiumSite Not Available
Research Site
Brasilia, 71625-009
BrazilSite Not Available
Research Site
Brasília, 71625-009
BrazilSite Not Available
Research Site
Brasília 3469058, 71625-009
BrazilSite Not Available
Research Site
Porto Alegre, 90610-261
BrazilSite Not Available
Research Site
Porto Alegre 3452925, 90610-261
BrazilSite Not Available
Research Site
Recife, 50740-465
BrazilSite Not Available
Research Site
Recife 3390760, 50740-465
BrazilSite Not Available
Research Site
Salvador, 40050-410
BrazilSite Not Available
Research Site
Salvador 3450554, 40050-410
BrazilSite Not Available
Research Site
Sao Paulo, 05403-900
BrazilSite Not Available
Research Site
São Paulo, 05403-900
BrazilSite Not Available
Research Site
São Paulo 3448439, 01409-902
BrazilSite Not Available
Research Site
Calgary, Alberta T2E 7Z4
CanadaSite Not Available
Research Site
Edmonton, Alberta T6G 2H7
CanadaSite Not Available
Research Site
Calgary 5913490, Alberta 5883102 T2E 7Z4
CanadaSite Not Available
Research Site
Winnepeg, Manitoba 6065171 R3E 3P4
CanadaSite Not Available
Research Site
Ottawa, Ontario K1H 8L1
CanadaSite Not Available
Research Site
Beijing, 100045
ChinaSite Not Available
Research Site
Beijing 1816670, 100045
ChinaSite Not Available
Research Site
Guangzhou, 510623
ChinaSite Not Available
Research Site
Guangzhou 1809858, 510623
ChinaSite Not Available
Research Site
Shanghai, 2000127
ChinaSite Not Available
Research Site
Shanghai 1796236, 2000127
ChinaSite Not Available
Research Site
Shenzhen, 518053
ChinaSite Not Available
Research Site
Shenzhen 1795565, 518053
ChinaSite Not Available
Research Site
Helsinki, 00290
FinlandSite Not Available
Research Site
Helsinki 658225, 00290
FinlandSite Not Available
Research Site
Le Kremlin Bicêtre, 94270
FranceSite 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
Ashkelon, 7830604
IsraelSite Not Available
Research Site
Ashkelon 295620, 7830604
IsraelSite Not Available
Research Site
Beer Sheva, 8410101
IsraelSite Not Available
Research Site
Petach-Tikva, 4920235
IsraelSite Not Available
Research Site
Petah Tikva 293918, 4920235
IsraelSite Not Available
Research Site
Petah-Tikva, 4920235
IsraelSite Not Available
Research Site
Ramat Gan, 52621
IsraelSite Not Available
Research Site
Ramat Gan 293788, 52621
IsraelSite Not Available
Research Site
Bologna, 40138
ItalySite 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
Rome, 00050
ItalySite Not Available
Research Site
Seoul, 05505
Korea, Republic ofSite Not Available
Research Site
Campeche, 24050
MexicoSite Not Available
Research Site
Chihuahua, 31238
MexicoSite Not Available
Research Site
Chihuahua City 4014338, 31238
MexicoSite Not Available
Research Site
Ciudad de Mexico, 14389
MexicoSite Not Available
Research Site
Mexico City, '14080
MexicoSite Not Available
Research Site
Zapopan, 45040
MexicoSite Not Available
Research Site
Kraków, 31-503
PolandSite Not Available
Research Site
Lodz 3093133, 93-338
PolandSite Not Available
Research Site
Warszawa, 01-211
PolandSite Not Available
Research Site
Łódź, 93-338
PolandSite Not Available
Research Site
Bucharest, 011863
RomaniaSite Not Available
Research Site
Bucharest 683506, 011863
RomaniaSite Not Available
Research Site
Bucureşti, 011863
RomaniaSite Not Available
Research Site
Madrid, 28046
SpainSite Not Available
Research Site
Madrid 3117735, 28046
SpainSite Not Available
Research Site
Vitoria, 01009
SpainSite Not Available
Research Site
Vitoria-Gasteiz 3104499, 01009
SpainSite Not Available
Research Site
Stockholm, 17176
SwedenSite Not Available
Research Site
Stockholm 2673730, 17176
SwedenSite Not Available
Research Site
Taipei, 100
TaiwanSite Not Available
Research Site
Taipei 1668341, 100
TaiwanSite Not Available
Research Site
Taoyuan, 333
TaiwanSite Not Available
Research Site
Taoyuan District 1667905, 333
TaiwanSite Not Available
Research Site
Bangkok, 10400
ThailandSite Not Available
Research Site
Chaingmai, 50200
ThailandSite Not Available
Research Site
Hat Yai, 90110
ThailandSite Not Available
Research Site
Muang, 50200
ThailandSite Not Available
Research Site
Ratchathewi, 10400
ThailandSite Not Available
Research Site
Songkla, 90110
ThailandSite Not Available
Research Site
Altındağ-Ankara, 06230
TurkeySite Not Available
Research Site
Ankara, 06100
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
Ankara 323786, 06560
Turkey (Türkiye)Site Not Available
Research Site
Bursa 750269, 16059
Turkey (Türkiye)Site Not Available
Research Site
Erzurum 315368, 25240
Turkey (Türkiye)Site Not Available
Research Site
Istanbul 745044, 34899
Turkey (Türkiye)Site Not Available
Research Site
Birmingham, B4 6NH
United KingdomSite Not Available
Research Site
Birmingham 2655603, B4 6NH
United KingdomSite Not Available
Research Site
Manchester,
United KingdomSite Not Available
Research Site
Baltimore, Maryland 21287
United StatesSite Not Available
Research Site
Baltimore 4347778, Maryland 4361885 21287
United StatesSite Not Available
Research Site
Kansas City, Missouri 64108
United StatesSite Not Available
Research Site
Kansas City 4393217, Missouri 4398678 64108
United StatesSite Not Available
Research Site
Durham, North Carolina 27705
United StatesSite Not Available
Research Site
Durham 4464368, North Carolina 4482348 27705
United StatesSite Not Available
Research Site
Hanoi, 100000
VietnamSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.