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TerminatedNCT02399839Updated Dec 16, 2022

Global Lomitapide Pregnancy Exposure Registry

An observational study in Pregnancy, sponsored by Amryt Pharma. Terminated at 1 site in Germany. Open to female participants. Per ClinicalTrials.gov, last updated 2022-12-16.

Sponsored by Amryt Pharma · Observational

Why this study was terminated
The PER objective has been integrated into the LOWER protocol.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
5
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pregnancy
03

In context

Lead sponsor

Amryt Pharma is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant Females

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

Exclusion Criteria:

  • Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
5 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Interventions

  • Druglomitapide

    As prescribed by Physician.

    Also known as: Juxtapid, Lojuxta

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 Years

07

Study locations

1 site
  • Klinikum der Universität München
    München, Bavaria 80336, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02399839
Lead sponsor
Amryt Pharma
Responsible party
Sponsor
First posted
Mar 26, 2015
Start date
Oct 2014
Primary completion
Dec 2022
Completion
Dec 2022
Last update
Dec 16, 2022

Study contacts

Sallyann O'Brien
study director · Amryt Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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