LOWER: Lomitapide Observational Worldwide Evaluation Registry (AEGR-733-025)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS5326
• Study ID:
  47071
• Official title and acronym:
  LOWER: Lomitapide Observational Worldwide Evaluation Registry (AEGR-733-025)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Greece

  Italy

  Netherlands

  United Kingdom

  United States
• Study description:
  The registry is designed to evaluate the long-term safety and effectiveness of lomitapide in clinical practice. The objectives of the registry are: ; • To evaluate the occurrence of the following in patients treated with lomitapide: Hepatic abnormalities, Gastrointestinal (GI) events, Small bowel, hepatic, colorectal and pancreatic tumours, Events associated with coagulopathy, Major Adverse Cardiovascular Events (MACE) events, Death, including cause of death, ; • To evaluate the occurrence and outcomes of pregnancy in females of reproductive potential treated with lomitapide, with or without consultation with a teratologist and regardless of the outcome of the pregnancy (live birth, elective or spontaneous abortion or still birth). The outcomes of primary interest are major congenital anomalies. ; • To evaluate the long-term effectiveness of lomitapide in maintaining control of serum lipid levels in clinical practice., ; • To evaluate whether prescribers of lomitapide enroled at registry sites are following the screening and monitoring recommendations as specified in the product information (PI) and the prescriber educational materials aimed at risk minimisation.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Metropolitan Hospital

Radboud university medical center (Radboudumc)

Netherlands

Assitance Publique des Hopitaux de Marseille (APHM)

France

Erasmus Medical Centre Rotterdam

ITA- AOU Paolo Giaccone di Palermo
ITA- AOU policlinico di Bari
ITA- Fondazione Toscana Gabriele Monasterio (FTGM)
ITA- AOU San Luigi Gonzaga
ITA- AOU Federico II (for 2 sites)
ITA- Sapienza Università di Roma
ITA- Azienda Ospedaliera G. Brotzu
ITA- AOU Policlinico S. Orsola-Malpighi
ITA- Università degli Studi Genova
ITA- AOUI Verona
ITA- Ospedale Bassini
ITA- AOU Mater Domini Catanzaro
ITA- AOU di Ferrara
ITA - Azienda Ospedaliera di Padova
FRA- CHU de Lille
FRA- CHU de Strasbourg
FRA- CHU - l'Assistance Publique - Hôpitaux de Marseille
FRA- HP - HU La Pitié-Salpêtrière – C.-Foix
FRA- Hopital Louis Pradel;
GRC- University General Hospital of Heraklion
GRC- Metropolitan Hospital
GRC- National and Kapodistrian University of Athens

Study timelines

Date when funding contract was signed

Planned:02/12/2013

Actual:20/12/2013

Study start date

Planned:01/03/2014

Actual:18/03/2014

Data analysis start date

Planned:18/03/2028

Actual:02/03/2026

Date of final study report

Planned:30/09/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amryt, DAC

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)