Clinical Trial: Pharmacokinetic, and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 2a, Randomized, Multicenter, Open-Label, Pharmacokinetic, and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia
Brief Summary: The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of asfotase alfa in adult patients with pediatric-onset HPP.
Detailed Summary:
Sponsor: Alexion Pharmaceuticals
Current Primary Outcome: Change in PPi from Baseline to pre-3rd dose in Week 9 [ Time Frame: Baseline to Week 9 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change in PLP from Baseline to pre-3rd dose in Week 9 [ Time Frame: Baseline to Week 9 ]
Original Secondary Outcome: Same as current
Information By: Alexion Pharmaceuticals
Dates:
Date Received: May 23, 2016
Date Started: June 2016
Date Completion:
Last Updated: February 17, 2017
Last Verified: February 2017