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

Contact details

Zakaria Medeghri

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
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