Global Lomitapide Pregnancy Exposure Registry

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02399839

Enrollment

Registered

2015-03-26

Start date

2014-10-31

Completion date

2022-12-31

Last updated

2022-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

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.

Interventions

DRUGlomitapide

As prescribed by Physician.

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026