Global Lomitapide Pregnancy Exposure Registry

Terminated

• Conditions: Pregnancy

• Registration Number: NCT02399839
• Lead Sponsor: Amryt Pharma

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-26
• Status Verified: 2022-12
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy	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.

Trial Locations

Locations (1)

Klinikum der Universität München; 🇩🇪 München, Bavaria, Germany