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NCT02399839 Clinical Trial

Global Lomitapide Pregnancy Exposure Registry

Pregnancy Clinical Trial

Official title:
Global Lomitapide Pregnancy Exposure Registry

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02399839
Other study ID # AEGR-733-027
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 2014
Est. completion date December 2022

Study information
Verified date December 2022
Source Amryt Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• lomitapide
As prescribed by Physician.

Locations
Country Name City State
Germany Klinikum der Universität München München Bavaria

Sponsors (1)
Lead Sponsor Collaborator
Amryt Pharma

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy 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. 2 Years
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