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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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19 February 2015 |
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Main ID: |
NCT01412034 |
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Date of registration:
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05/08/2011 |
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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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Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects
MODE |
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Scientific title:
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Modifying Orphan Disease Evaluation (MODE) Study: A Multicenter, Open-label Study of the Effects of CER-001 on Plaque Volume in Subjects With Homozygous Familial Hypercholesterolemia (HoFH) |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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23 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01412034 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Italy
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Netherlands
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United Kingdom
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United States
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Contacts
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Name:
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John J. Kastelein, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Amsterdam Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female subject 12 years or older
- Subject presents with Homozygous FH
Exclusion Criteria:
- Weight >100 kg
- Subjects with significant health problems in the recent past including blood
disorders, cancer, or digestive problems
- Female subjects of child-bearing potential
- Known major hematologic, renal , hepatic, metabolic, gastrointestinal or endocrine
dysfunction
- Contraindication to MRI scanning that would preclude the use of contrast-enhanced
3TMRI
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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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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Drug: CER-001
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Primary Outcome(s)
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Percent change from baseline to follow-up in carotid mean vessel wall area
[Time Frame: Baseline then 6 months and/or ~2 weeks post final dose]
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Secondary Outcome(s)
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Change in carotid vessel wall volume
[Time Frame: Baseline then 6 months and/or ~2 weeks post final dose]
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Secondary ID(s)
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CER-001-CLIN-003
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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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