Global Lomitapide Pregnancy Exposure Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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lomitapide

As prescribed by Physician.

Intervention Type DRUG

Other Intervention Names

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Juxtapid Lojuxta

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sallyann O'Brien

Role: STUDY_DIRECTOR

Amryt Pharmaceuticals

Locations

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Klinikum der Universität München

München, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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AEGR-733-027

Identifier Type: -

Identifier Source: org_study_id