Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan

Study Identifier:
AA-HPP-409
ClinicalTrials.gov Identifier:
NCT02531867
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Biological: Asfotase Alfa
Date
Jun 2015 - Nov 2015
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Patient or parent (or legal guardian) must provide written informed consent prior to the performance of any study-related procedures and must be willing to comply with study procedures. Where appropriate and required by local regulations, patient assent for participation must also be obtained.
  • Patient has completed the investigator-initiated clinical study (HPPJEAP-01) protocol for asfotase alfa
Exclusion Criteria
  • Patient has a documented form of rickets caused by a condition other than HPP, including, but not limited to, rickets caused by 25(OH) vitamin D deficiency
  • Patient has serum calcium and/or phosphorus levels below the normal range
  • Patient is pregnant or lactating
  • Patient received treatment with bisphosphonates within 2 years prior to the Screening visit
  • Patient has a documented sensitivity to any of the components of asfotase alfa
  • Patient is currently enrolled in any other program or clinical study involving an investigational new drug, device, or treatment for HPP (eg, bone marrow transplantation)
  • Patient has clinically significant other disease in the opinion of the Investigator, defined as any other non HPP-related condition for which the patient is considered medically unstable.
Sex
Female & Male
Age
N/A

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Biological: Asfotase Alfa
Date
Jun 2015 - Nov 2015
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Patient or parent (or legal guardian) must provide written informed consent prior to the performance of any study-related procedures and must be willing to comply with study procedures. Where appropriate and required by local regulations, patient assent for participation must also be obtained.
  • Patient has completed the investigator-initiated clinical study (HPPJEAP-01) protocol for asfotase alfa
Exclusion Criteria
  • Patient has a documented form of rickets caused by a condition other than HPP, including, but not limited to, rickets caused by 25(OH) vitamin D deficiency
  • Patient has serum calcium and/or phosphorus levels below the normal range
  • Patient is pregnant or lactating
  • Patient received treatment with bisphosphonates within 2 years prior to the Screening visit
  • Patient has a documented sensitivity to any of the components of asfotase alfa
  • Patient is currently enrolled in any other program or clinical study involving an investigational new drug, device, or treatment for HPP (eg, bone marrow transplantation)
  • Patient has clinically significant other disease in the opinion of the Investigator, defined as any other non HPP-related condition for which the patient is considered medically unstable.

Protocol 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.

Trial Locations

No locations found.