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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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21 August 2023 |
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Main ID: |
NCT02354079 |
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Date of registration:
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14/01/2015 |
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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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HYPOCHOL : A Genetically-based Strategy to Identify New Targets in Cholesterol Metabolism
HYPOCHOL |
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Scientific title:
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HYPOCHOL : A Genetically-based Strategy to Identify New Targets in Cholesterol Metabolism |
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Date of first enrolment:
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January 7, 2016 |
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Target sample size:
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435 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02354079 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Charlotte AUTHIER, Doctor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Health Care Centers of French Health Insurance in Saint-Nazaire |
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Name:
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Didier GOXE |
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Address:
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Telephone:
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Email:
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Affiliation:
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Health Care Centers of French Health Insurance in La Roche sur Yon |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- For index cases without family screening:
o Patient with HBL: fasting LDL-C = 50 mg/dl.
- For familial affected cases:
- Relative with HBL: fasting LDL-C = 80 mg/dl and/or Apo B = 50 mg/dl and at least
one related family case suffering from HBL.
All subjects, including familial non-affected cases, must give written consent (dated and
signed) to participate at the constitution of biobank (including DNA samples and urine
samples).
Exclusion Criteria:
- Use of lipid-lowering drugs (statins, fibrates, ezetimibe, bile-acid sequestering
resin) or nutraceuticals known to affect lipids (red yeast rice, margarine and dairy
with plant sterol)
- Patient screened within an extreme metabolic disturbance (emergency situations,
sepsis, hospitalization in intensive care unit)
- Patients with hyperthyroidism, severe liver failure, end stage chronic kidney disease,
serious pancreatic failure, anemia related to thalassemia or sickle cell disease,
strict vegan diet or malnutrition
- Refusal of the patient or his legal representative to participate in the study"
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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Hypobetalipoproteinemia
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Intervention(s)
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Genetic: hypobetalipoproteinemia genetic and genotypic screening
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Primary Outcome(s)
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type and number of genetic abnormalities leading to FHBL
[Time Frame: ten years]
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Secondary ID(s)
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RC14_0400
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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