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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000022603 |
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Date of registration:
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04/06/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Non-randomized, prospective, non-controlled study of changes of lipid parameters after introduction of evolocumab in patients with heterozygous familial hypercholesterolemia under LDL-apheresis therapy.
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Scientific title:
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Non-randomized, prospective, non-controlled study of changes of lipid parameters after introduction of evolocumab in patients with heterozygous familial hypercholesterolemia under LDL-apheresis therapy. - Impact of evelocumab in homozygous familial hypercholesterolemia under LDL-apheresis. |
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Date of first enrolment:
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2016/06/06 |
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Target sample size:
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2 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026056 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Masa-aki Kawashiri |
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Address:
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13-1 Takara-machi, Kanazawa
Japan |
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Telephone:
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076-265-2251 |
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Email:
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mk@med.kanazawa-u.ac.jp |
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Affiliation:
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Kanazawa University Hospital Department of Cardiology |
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Name:
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Masa-aki Kawashiri |
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Address:
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13-1 Takara-machi, Kanazawa
Japan |
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Telephone:
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076-265-2251 |
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Email:
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mk@med.kanazawa-u.ac.jp |
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Affiliation:
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Kanazawa University Hospital Department of Cardiology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Myocardial infarction or unstable angina within 8 weeks Severe anemia (Hb <10g/dL) Allergy against evolocumab Immunosupressive therapy Severe hepatic disorder (ASTorALT>100IU/L) Severe renal disorder (BUN>40mg/dL or Cre>2.0mg/dL) (Possible of) pregnancy
Age minimum:
20years-old
Age maximum:
100years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Homozygous familial hypercholesterolemia
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Intervention(s)
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Subcutaneous injection of evolocumab
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Primary Outcome(s)
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Comparison of the time constant average levels of LDL-C and apoB before and after evolocumab thereapy.
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Source(s) of Monetary Support
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Kanazawa University Hospital
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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