Pharmacokinetic and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP)

Exclusion Criteria

• •1. Investigational site personnel directly affiliated with this study and/or their immediate families. Immediate family was defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
• •2. Employees of Alexion Pharmaceuticals.
• •3. Currently enrolled in a clinical study involving another study drug or non-approved use of a drug or device.
• •4. Participated, within the last 30 days, in a clinical study involving a study drug (other than the study drug used in this study).
• •5. Completed or withdrawn from this study or any other study investigating asfotase alfa in the previous 3 years.
• •6. Women who were pregnant, planning to become pregnant, or breastfeeding.
• •7. Serum 25-hydroxy Vitamin D levels below 20 nanogram (ng) per milliliter (mL) at Screening.
• •8. Screening serum creatinine or parathyroid hormone (PTH) levels ≥1.5 times the upper limit of normal.
• •9. Any medical condition, serious concurrent illness and/or injury, recent orthopedic surgery, or other extenuating circumstance that, in the opinion of the Investigator, may have significantly interfered with study compliance or study endpoints.
• •10. Prior treatment with bisphosphonates within 2 years of study entry for any length of time or for more than 2 consecutive years at any prior timepoint.
• •11. Treatment with PTH, strontium, or sclerostin inhibitors within 6 months prior to the first dose of study drug.
• •12. Unwilling or unable to comply with the use of a data collection device on which study participants directly recorded data.