Global Lomitapide Pregnancy Exposure Registry

Amryt Pharma

Status: Terminated

Conditions: Pregnancy

Treatments: Drug: lomitapide

Study type: Observational

Funder types: Industry

Identifiers

NCT02399839

AEGR-733-027

Details and patient eligibility

About

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

Full description

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.

Enrollment: 5 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.