Global Lomitapide (Juxtapid and Lojuxta) Pregnancy Exposure Registry (PER)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20497
• EU PAS number:
  EUPAS5329
• Study ID:
  20497
• Official title and acronym:
  Global Lomitapide (Juxtapid and Lojuxta) Pregnancy Exposure Registry (PER)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Austria

  Brazil

  Canada

  Denmark

  France

  Germany

  Italy

  Netherlands

  Norway

  Poland

  Spain

  Sweden

  Taiwan

  United Kingdom

  United States
• Study description:
  Aegerion Pharmaceuticals, the Market Authorization Holder (MAH) for lomitapide (Juxtapid and Lojuxta), is seeking to evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to the first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.This is a global, longitudinal, observational study. Data will be collected at enrolment and periodically during pregnancy from prescribers, gynaecologists, paediatricians and other Health Care Providers (HCPs) who may be caring for the patient during the pregnancy or caring for the child. HCPs will be contacted during the pregnancy (each trimester), within 4 weeks after the estimated delivery date (EDD), and for paediatric follow-up at 12 weeks of age and at 12 months of age. In the US and in other countries where patient contact is possible, data will also be collected directly from patients during each trimester, at the EDD, and, for paediatric patients, at 12 weeks and 12 months. The PER will include pregnancies identified from any country where the Aegerion Lomitapide Observational Worldwide Evaluation Registry (LOWER) is conducted including North America and Europe. The registry is non-interventional, all treatment decisions are made at the discretion of the patient’s HCP, and are not mandated by the study design or protocol.
• Study status:
  Planned

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Planned: 15/10/2013

Study start date

Planned: 15/09/2014

Date of final study report

Planned: 13/07/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Aegerion Pharmaceuticals

Study protocol

Initial protocol

aegr-733-027-V3 FINAL protocol 21 Nov2013

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)