The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Global Lomitapide Pregnancy Exposure Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02399839
Recruitment Status : Terminated (The PER objective has been integrated into the LOWER protocol.)
First Posted : March 26, 2015
Last Update Posted : December 16, 2022
Sponsor:
Information provided by (Responsible Party):
Amryt Pharma

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 5 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
Actual Primary Completion Date : December 2022
Actual Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy
Drug Information available for: Lomitapide

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Germany
Klinikum der Universität München
München, Bavaria, Germany, 80336
Sponsors and Collaborators
Amryt Pharma
Investigators
Layout table for investigator information
Study Director: Sallyann O'Brien Amryt Pharmaceuticals
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
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 16, 2022
Last Verified: December 2022