- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04815005
HoFH, the International Clinical Collaborators Registry (HICC)
HoFH, the International Clinical Collaborators - A Global HoFH Data-sharing Platform
Study Overview
Status
Conditions
Detailed Description
The HICC registry is an observational, multicenter, international registry collecting de-identified clinical and genetic information from patients with homozygous Familial Hypercholesterolemia (HoFH) worldwide.
Patients are eligible to be enrolled in the registry based on the diagnosis of HoFH by the treating clinician, irrespective of how the diagnosis was made. To generate up-to-date data reflecting current rather than historic practice, patients who died or were lost to follow-up prior to 2010 are excluded.
Anonymized data on demographics, type of HoFH diagnosis (clinical and/or based on the results of a genetic test), genetic results, (cardiovascular) medical history, relevant family history, physical examination, laboratory measurements, lipid lowering treatment and cardiovascular imaging are collected for 3 different time points: at diagnosis, at enrolment and at time of best lipid profile (if this is different from time at enrolment). Data are collected using pre-definite electronic case report forms to ensure uniformity of data collected. Primary analysis will be cross-sectional (e.g. based on country of residence, age, etc)
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marina Cuchel, MD, PhD
- Phone Number: 2156627188
- Email: mcuchel@pennmedicine.upenn.edu
Study Contact Backup
- Name: Lauren Vincent, MRA
- Phone Number: 2156155448
- Email: laurv@pennmedicine.upenn.edu
Study Locations
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Amsterdam, Netherlands
- Recruiting
- Department of Vascular Medicine, Amsterdam UMC
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Contact:
- G. Kees Hovingh, MD, PhD
- Email: g.k.hovingh@amsterdamumc.nl
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Principal Investigator:
- G. Kees Hovingh, MD, PhD
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Cape Town, South Africa
- Recruiting
- Department of Medicine, Division of Lipidology and Hatter Institute for Cardiovascular Research in Africa, University of Cape Town
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Contact:
- Dirk J Blom
- Email: dirk.blom@uct.ac.za
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Principal Investigator:
- Dirk J Blom
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Johannesburg, South Africa
- Recruiting
- c. Carbohydrate and Lipid Metabolism Research Unit, Faculty of Health Sciences, University of Witwatersrand
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Contact:
- Frederick J Raal
- Email: frederick.raal@wits.ac.za
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Principal Investigator:
- Frederick J Raal, PhD
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
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Contact:
- Lauren Vincent, MRA
- Phone Number: 2156155448
- Email: laurv@pennmedicine.upenn.edu
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Contact:
- Marina Cuchel, MD, PhD
- Phone Number: 215-662-7188
- Email: mcuchel@pennmedicine.upenn.edu
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Principal Investigator:
- Marina Cuchel, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of homozygous familial hypercholesterolemia (HoFH) clinically of genetically determined
Exclusion Criteria:
- No diagnosis of HoFH
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HoFH
Patients diagnosed with HoFH by their physicians, either based on clinical or genetic criteria.
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Differences in diagnosis, genotype, lipid profile treatment allocation among HoFH patients worldwide.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants entered into the database
Time Frame: Through study completion, an average of 8 years
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Number of study participants with homozygous familial hypercholesterolemia
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Through study completion, an average of 8 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Untreated and treated LDL-C levels across world income regions
Time Frame: Through study completion, an average of 8 years
|
Number of treated versus number of untreated subjects with relevant LDL-C levels
|
Through study completion, an average of 8 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marina Cuchel, MD, PhD, University of Pennsylvania
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HICC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Homozygous Familial Hypercholesterolemia
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Novartis PharmaceuticalsCompletedElevated Cholesterol | Homozygous Familial Hypercholesterolemia | Heterozygous Familial Hypercholesterolemia | ASCVDUnited States, Canada, Czechia, Denmark, Germany, Hungary, Netherlands, Poland, South Africa, Spain, Sweden, Ukraine, United Kingdom
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Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
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-
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-
AkesoAD Pharmaceuticals Co., Ltd.CompletedHomozygous Familial HypercholesterolemiaChina
Clinical Trials on Demographics, diagnosis type, genotype, lipid profile, treatment allocation, country of residence.
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