Global Lomitapide Pregnancy Exposure Registry

Amryt Pharma1 site in 1 country5 target enrollmentOctober 2014

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

December 2022

Last Updated

3 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Amryt Pharma

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Pregnancy

Time Frame: 2 Years

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.