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Trial record 9 of 19 for:    lomitapide

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

Tracking Information
First Submitted Date March 23, 2015
First Posted Date March 26, 2015
Last Update Posted Date December 4, 2020
Study Start Date October 2014
Estimated Primary Completion Date March 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 2, 2020)
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.
Original Primary Outcome Measures
 (submitted: March 23, 2015)
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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Global Lomitapide Pregnancy Exposure Registry
Official Title Global Lomitapide Pregnancy Exposure Registry
Brief Summary To evaluate the outcomes of pregnancy in women treated with 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 Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pregnant Females
Condition Pregnancy
Intervention Drug: lomitapide
As prescribed by Physician.
Other Names:
  • Juxtapid
  • Lojuxta
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: March 23, 2015)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2028
Estimated Primary Completion Date March 2028   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02399839
Other Study ID Numbers AEGR-733-027
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Amryt Pharma
Study Sponsor Amryt Pharma
Collaborators Not Provided
Investigators
Study Director: Sallyann O'Brien Amryt Pharmaceuticals
PRS Account Amryt Pharma
Verification Date December 2020