Global Lomitapide Pregnancy Exposure Registry

Amryt Pharma5 enrolled

Overview

To evaluate the outcomes of pregnancy in women treated with lomitapide.

To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pregnancy

Interventions

lomitapideDRUG

As prescribed by Physician.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant females exposed to lomitapide at any time within 30 days prior to first day of the LMP or during pregnancy. Exclusion Criteria: * Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.

Locations (1)

Klinikum der Universität München

München, Bavaria, Germany

Outcomes

Primary Outcomes

Pregnancy

Time frame: 2 Years

Data from ClinicalTrials.gov

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