A National, Post-Registration, Observational Study of the Longterm Safety and Health Outcome of Patients Treated With Defitelio®, Including Patients With Severe Hepatic VOD After HSCT. (DEFIFRANCE Registry)

Study identification

• EU PAS number:
  EUPAS29649
• Study ID:
  46727
• Official title and acronym:
  A National, Post-Registration, Observational Study of the Longterm Safety and Health Outcome of Patients Treated With Defitelio®, Including Patients With Severe Hepatic VOD After HSCT. (DEFIFRANCE Registry)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  DEFIFRANCE is a French national registry of patients treated with Defitelio® in order to conduct a multicentre observational study comprising descriptive analysis and follow-up assessment of patients treated with Defitelio®.
• Study status:
  Planned

Research institutions and networks

Institutions

Jazz Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 20/01/2017

Study start date

Planned: 20/01/2017

Date of final study report

Planned: 31/07/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Jazz Pharmaceuticals

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable