UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022604 |
|---|---|
| Receipt number | R000026029 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2016/06/04 |
| Last modified on | 2020/02/13 20:44:38 |
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Basic information
Public title
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.
Acronym
Impact of evelocumab in heterozygous familial hypercholesterolemia under LDL-apheresis.
Scientific Title
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.
Scientific Title:Acronym
Impact of evelocumab in heterozygous familial hypercholesterolemia under LDL-apheresis.
Region
| Japan |
Condition
Condition
Heterozygous familial hypercholesterolemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the safety and the changes of lipid parameters after the introduction of evolocumab in the patients with heterozygous familial hypercholesterolemia under LDL-apheresis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the time constant average levels of LDL-C and apoB during LDL-apheresis and those under evolocumab thereapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subcutaneous injection of evolocumab
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Heterozygous familial hypercholesterolemic patients under LDL-apheresis therapy and stable lipid-lowering therapy including statins, ezetimibe, fibrates, resin, probucol, EPA, niacin, and vitamin E
Key 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
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masa-aki |
| Middle name | |
| Last name | Kawashiri |
Organization
Kanazawa University Hospital
Division name
Department of Cardiology
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2251
mk@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masa-aki |
| Middle name | |
| Last name | Kawashiri |
Organization
Kanazawa University Hospital
Division name
Department of Cardiology
Zip code
920-8641
Address
13-1 Takara-machi, Kanazawa
TEL
076-265-2251
Homepage URL
mk@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Innovative Clinical Research Center, Kanazawa Univrsity
Address
13-1 Takara-machi, Kanazawa
Tel
076-265-2048(7590)
crc.irb-knz@esct.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0021915017312820?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0021915017312820?via%3Dihub
Number of participants that the trial has enrolled
11
Results
Compared to biweekly LDL apheresis, biweekly evolocumab injection therapy is less expensive, less invasive, less time-consuming, and more effective in reducing atherogenic lipoprotein levels without severe adverse side effects.
Results date posted
| 2020 | Year | 02 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male and female patients with heterozygous familial hypercholesterolemia under stable biweekly LDL apheresis and medical therapy.
Participant flow
Eleven patients with HeFH undergoing biweekly LDL apheresis were enrolled and were subsequently switched to a biweekly subcutaneous injection of 140 mg of evolocumab.
Adverse events
nothing
Outcome measures
The primary endpoints were percent changes in mean LDL-C and apolipoprotein B (apoB) serum levels, which were averages of two different time point measurements, due to the switch in the treatment method.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026029
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