LOWER: Lomitapide Observational Worldwide Evaluation Registry

Study Identifier:
AEGR-733-025
ClinicalTrials.gov Identifier:
NCT02135705
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
1 855 303 2347 or [email protected]
See Study Publication Below
Recruiting

Study Details

Medical Condition
  • Homozygous Familial Hypercholesterolaemia (HoFH)
Study Drug
  • Drug: Lomitapide
Date
Mar 2014 - Mar 2028
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Patients of all ages, including minors, who have initiated commercial treatment with lomitapide prior to or at time of registry enrolment.
  • Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures or paediatric patients with the consent of a parent or legal guardian.
  • Patients ≥7 years of age (or above the age determined by the IRB/EC and in accordance with the local regulations and requirements) must also provide written informed assent forms.
Exclusion Criteria
  • Patients who are receiving lomitapide in clinical trials or through compassionate use, where patients are followed under a separate protocol.
  • Patients receiving an investigational agent, defined as any drug or biologic agent other than lomitapide that has not received market authorization in the country of participation, at time of lomitapide initiation and continuing to receive an investigational agent at time of registry enrolment. These patients may be enrolled if receiving lomitapide when the investigational agent is discontinued..
Healthy Volunteers
No

Protocol Summary

This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.

Study Locations

Location
Status
Location
Brookwood Baptist Medical Center
Birmingham, Alabama, United States, 35209
Status
Recruiting
Location
Springhill Physician Practices
Mobile, Alabama, United States, 36608
Status
Terminated
Location
Northern Arizona Healthcare
Cottonwood, Arizona, United States, 86326
Status
Recruiting
Location
One Medical
Gilbert, Arizona, United States, 85296
Status
Withdrawn
Location
Scottsdale Family Health
Phoenix, Arizona, United States, 85018
Status
Recruiting
Location
Pima Heart
Tucson, Arizona, United States, 85718
Status
Terminated
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Study Publications

Larrey D, D'Erasmo L, O'Brien S, Arca M; Italian Working Group on Lomitapide. Long-term hepatic safety of lomitapide in homozygous familial hypercholesterolaemia. Liver Int. 2023 Feb;43(2):413-423. doi: 10.1111/liv.15497. Epub 2022 Dec 30.Giammanco A, Cefalu AB, Noto D, Averna MR. Therapeutic Options for Homozygous Familial Hypercholesterolemia: The Role of Lomitapide. Curr Med Chem. 2020;27(23):3773-3783. doi: 10.2174/0929867326666190121120735.