MEASuRE: Metreleptin Effectiveness and Safety Registry

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001052
• Study ID:
  1000001052
• Official title and acronym:
  MEASuRE: Metreleptin Effectiveness and Safety Registry
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  United Kingdom

  United States
• Study description:
  A non-interventional, multicenter, prospective observational registry designed to evaluate the long-term safety and effectiveness of metreleptin under routine clinical practice conditions in the US and EEA. ; ; The target study population will include patients who have taken at least one dose of commercial metreleptin. Inclusion criteria are broad so as to enable inclusion of a representative population of patients taking metreleptin as per usual clinical practice.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Chiesi Farmaceutici

IQVIA

United Kingdom

N/A

Study timelines

Date when funding contract was signed

Planned:08/03/2016

Actual:08/03/2016

Study start date

Planned:11/10/2016

Actual:11/10/2016

Data analysis start date

Planned:01/07/2017

Actual:01/07/2017

Date of interim report, if expected

Planned:30/09/2026

Date of final study report

Planned:31/03/2032

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Chiesi Farmaceutici S.p.A

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)
• Regulatory procedure number:
  EEA: EMEA/H/C/4218/SOB001 IND 050259 US: PMR 2456‑1

Other study registration identification numbers and links

MEASuRE AEGR-734-400