LOWER: Lomitapide Observational Worldwide Evaluation Registry

ReclutandoClinicalTrials.gov

ID: NCT02135705Tipo: OBSERVATIONALInicio: 18 de mar de 2014Fin estimado: 1 de sept de 2028

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

To evaluate the occurrence of adverse events of special interest, long term effectiveness of lomitapide, and to evaluate whether prescribers of lomitapide are following screening and monitoring recommendations as specified in product labeling.

Elegibilidad

Sexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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..

Intervenciones

drug

Lomitapide

As prescribed by Physician.

Ubicaciones

Clinica de Salud de Chaco

Reconquista, Chaco CPA, Argentina

Dario Gomez, MD · dariogomez@ciudad.com.ar · (54)(9362) 453-6261

RECRUITING

Patrocinadores

PrincipalAmryt Pharma

Contactos

Janet Boylan

CONTACT

Janet.Boylan@AmrytPharma.com 1 855 303 2347

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