Hypophosphatasia Clinical Trial
Official title:
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
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
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Completed |
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Evaluate and Monitor Physical Performance of Adults Treated With Asfotase Alfa for Hypophosphatasia
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Recruiting |
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Natural History Study of Patients With Hypophosphatasia (HPP)
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Completed |
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Burden of Disease in Hypophosphatasia (HPP)
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N/A | |
Enrolling by invitation |
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Early Check: Expanded Screening in Newborns
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Active, not recruiting |
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Not yet recruiting |
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Prospective, Longitudinal, Observational Registry of Adult Patients With Hypophosphatasia (REG-HYPO)
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Completed |
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Characterisation of Adult-Onset Hypophosphatasia
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Completed |
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Health Burden of Hypophosphatasia
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Completed |
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Phase 1/Phase 2 | |
Recruiting |
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Phase 3 | |
Recruiting |
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A Prospective Sub-Study of the Global Hypophosphatasia Registry
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Completed |
NCT02797821 -
Pharmacokinetic and Dose Response Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia (HPP)
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Phase 2 | |
Completed |
NCT01163149 -
Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)
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Phase 2 | |
Completed |
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Unraveling Genetics of HypoPhosPhatasia (HPP Genetics)
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Completed |
NCT01406977 -
Dose Escalation Study to Evaluate the Safety and Tolerability of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP)
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Phase 2 | |
Recruiting |
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Completed |
NCT01176266 -
Open-Label Study of Asfotase Alfa in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)
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Phase 2/Phase 3 | |
Withdrawn |
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Safety and Efficacy Study of ENB-0040 in Juvenile Patients With Hypophosphatasia (HPP)
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Phase 2 | |
Active, not recruiting |
NCT04222452 -
The PORTRAIT Study
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Recruiting |
NCT06079281 -
Phase 3 Study of ALXN1850 Versus Placebo in Adolescent and Adult Participants With HPP Who Have Not Previously Been Treated With Asfotase Alfa
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Phase 3 |