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LOWER: Lomitapide Observational Worldwide Evaluation Registry

Homozygous Familial Hypercholesterolemia

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    0 and up

Participation 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..

Study Location

Robarts Research Institute
Robarts Research Institute
London, Ontario
Canada

Contact Study Team

Primary Contact

Robert Hegele, MD

[email protected]
(519) 931-5271
Nova Scotia Health Authority
Nova Scotia Health Authority
Halifax, Nova Scotia
Canada

Contact Study Team

Primary Contact

Thomas Ransom, MD

[email protected]
(902) 473-3712
Ecogene-21
Ecogene-21
Chicoutimi, Quebec
Canada

Contact Study Team

Primary Contact

Daniel Gaudet, MD

[email protected]
(418) 541-1077
McGill University
McGill University
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Jacques Genest, MD

[email protected]
(514) 934-1934
Study Sponsored By
Amryt Pharma
Participants Required
More Information
Study ID: NCT02135705