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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 (2 to < 12 years of age) Participants with Hypophosphatasia (HPP) Previously Treated with Asfotase Alfa

Status: Recruiting

This is a study to evaluate the safety and efficacy of ALXN1850 in pediatric participants with hypophosphatasia who have been treated with asfotase alfa for at least 6 months.

I'm interested

Sex: Male or Female
Age Group: Up to 18 years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 2 to 11 years old
• diagnosis of Hypophosphatasia (HPP)
• treated with 6 mg/kg/ week of asfotase alfa via subcutaneous injection administered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for at least 6 months
Exclusion Criteria:

• primary or secondary hyperparathyroidism
• hypoparathyroidism, unless secondary to HPP
• any new fracture within past 12 weeks
• body weight less than 10 kg (22 pounds)
Conditions:

Children's Health, Rare Diseases

Keywords:

HPP, Hypophosphatasia

Study Contact: Kyriakie Sarafoglou - saraf010@umn.edu
Principal Investigator: Kyriakie Sarafoglou
IRB Number: STUDY00020817

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