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Global Lomitapide Pregnancy Exposure Registry

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ClinicalTrials.gov Identifier: NCT02399839
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2015
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Amryt Pharma

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

Condition or disease Intervention/treatment
Pregnancy Drug: 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Global Lomitapide Pregnancy Exposure Registry
Study Start Date : October 2014
Estimated Primary Completion Date : March 2028
Estimated Study Completion Date : March 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Lomitapide


Intervention Details:
  • Drug: lomitapide
    As prescribed by Physician.
    Other Names:
    • Juxtapid
    • Lojuxta


Primary Outcome Measures :
  1. Pregnancy [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant Females
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399839


Locations
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Germany
Klinikum der Universität München
München, Bavaria, Germany, 80336
Sponsors and Collaborators
Amryt Pharma
Investigators
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Study Director: Sallyann O'Brien Amryt Pharmaceuticals
Additional Information:

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Responsible Party: Amryt Pharma
ClinicalTrials.gov Identifier: NCT02399839    
Other Study ID Numbers: AEGR-733-027
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020