CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 13 enrolled
Drug / intervention
Asfotase Alfabiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02531867
NCT02531867Phase 4Completed
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A Multicenter, Post-Approval Clinical Study for Asfotase Alfa (Human Recombinant Tissue-nonspecific Alkaline Phosphatase Fusion Protein) Treatment for Patients With Hypophosphatasia (HPP) in Japan

Alexion Pharmaceuticals, Inc.·interventional·Posted Aug 25, 2015·Updated May 8, 2017

In Brief

A Phase 4 clinical trial evaluating Asfotase Alfa for Hypophosphatasia. Completed, enrolled 13 participants.

Detailed Summary

This is a multicenter study in Japan. Eleven sites which have already participated in the investigator-initiated clinical study (Early Access Program) will participate in this study.The objective of this study is to gain further information on the safety and efficacy of treatment with asfotase alfa.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypophosphatasia
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 25, 2015
Enrollment StartJun 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.9 years ago

Interventions

Asfotase Alfabiological