Effect of CER-001 on Plaque Volume in Homozygous Familial Hypercholesterolemia (HoFH) Subjects (MODE)
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ClinicalTrials.gov Identifier: NCT01412034 |
Recruitment Status
:
Completed
First Posted
: August 8, 2011
Last Update Posted
: August 18, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Homozygous Familial Hypercholesterolemia | Drug: CER-001 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: CER-001
Open label single arm study of CER-001
|
Drug: CER-001
Biweekly infusion
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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 ]Percent change from baseline to follow-up in carotid mean vessel wall area
- Change in carotid vessel wall volume [ Time Frame: Baseline then 6 months and/or ~2 weeks post final dose ]Percent change in carotid vessel wall volume , as assessed by 3TMRI, from the baseline measurement to the follow up taken ~2 weeks following the final dose of study medication.

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412034
United States, Connecticut | |
Clinical Research Facility | |
Hartford, Connecticut, United States, 06102 | |
United States, New York | |
Clinical Research Facility | |
N. Massapequa, New York, United States, 11758 | |
Canada, Quebec | |
Clinical Research Facility | |
Chicoutimi, Quebec, Canada, G7H 7P2 | |
Canada | |
Clinical Research Facility | |
Quebec, Canada, G1V4M6 | |
Italy | |
Clinical Research Facility | |
Rome, Italy, 100161 | |
Netherlands | |
Clinical Research Facility | |
Amsterdam, Netherlands, 1105AZ | |
Clinical Research Facility | |
Maastricht, Netherlands, 6229 HX | |
Clinical Research Facility | |
Nijmegen, Netherlands, 6500 HB | |
United Kingdom | |
Clinical Research Facility | |
Manchester, United Kingdom, M13 9WL |
Principal Investigator: | John J. Kastelein, MD PhD | Amsterdam Medical Center |
Publications of Results:
Other Publications:
Responsible Party: | Cerenis Therapeutics, SA |
ClinicalTrials.gov Identifier: | NCT01412034 History of Changes |
Other Study ID Numbers: |
CER-001-CLIN-003 |
First Posted: | August 8, 2011 Key Record Dates |
Last Update Posted: | August 18, 2015 |
Last Verified: | July 2015 |
Keywords provided by Cerenis Therapeutics, SA:
Homozygous Familial Hypercholesterolemia Familial Hypercholesterolemia HDL mimetic ApoA-1 |
Additional relevant MeSH terms:
Hypercholesterolemia Hyperlipoproteinemia Type II Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders |
Metabolic Diseases Lipid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |