- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02399839
Global Lomitapide Pregnancy Exposure Registry
December 2, 2020 updated by: Amryt Pharma
To evaluate the outcomes of pregnancy in women treated with lomitapide.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
München, Bavaria, Germany, 80336
- Klinikum der Universitat Munchen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant Females
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sallyann O'Brien, Amryt Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
March 1, 2028
Study Completion (Anticipated)
March 1, 2028
Study Registration Dates
First Submitted
March 23, 2015
First Submitted That Met QC Criteria
March 23, 2015
First Posted (Estimate)
March 26, 2015
Study Record Updates
Last Update Posted (Actual)
December 4, 2020
Last Update Submitted That Met QC Criteria
December 2, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- AEGR-733-027
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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