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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02531867 |
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Date of registration:
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11/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
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Scientific title:
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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 |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02531867 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Contacts
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Name:
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Kenji Fujita, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Monitor |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. 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.
2. Patient has completed the investigator-initiated clinical study (HPPJEAP-01) protocol
for asfotase alfa
Exclusion Criteria:
1. 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
2. Patient has serum calcium and/or phosphorus levels below the normal range
3. Patient is pregnant or lactating
4. Patient received treatment with bisphosphonates within 2 years prior to the Screening
visit
5. Patient has a documented sensitivity to any of the components of asfotase alfa
6. 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)
7. 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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypophosphatasia
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Intervention(s)
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Biological: Asfotase Alfa
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Primary Outcome(s)
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Number of Participants With Adverse Events (AEs) Including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs)
[Time Frame: Events that occurred between the first dose of asfotase alfa and the completion of the patient's last visit, which was up to 5 months.]
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Secondary ID(s)
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AA-HPP-409
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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