Study identification

EU PAS number

EUPAS104818

Study ID

105892

Official title and acronym

A Multi-country, Non-interventional, Retrospective Drug Utilization Study in Haematological Malignancy Patients Treated for Probable or Proven Invasive Aspergillosis (AmBiVor)

DARWIN EU® study

No

Study countries

Belgium
France
Germany
Spain
United Kingdom

Study description

GS-EU-131-6385: This was a real-world, non-interventional, multi-country, retrospective chart review study using patient medical record data collected from 15 hospitals in 5 European countries (Belgium, France, Germany, Spain, and the United Kingdom (UK)). This was a study of Haematological malignancy patients (patients who have undergone Haematopoietic stem-cell transplantation HSCT, acute myeloid leukemia AML, myelodysplastic syndromes MDS and acute lymphoblastic leukaemia ALL) with a diagnosis of documented probable or proven IA (Invasive Aspergillosis) and who received at least 1 dose of AmBisome or voriconazole as primary treatment from 01 January 2014 to 31 December 2019. The primary objective of this study was to describe demographic, clinical and treatment patterns/sequences in haematologic malignancy patients treated either with AmBisome or voriconazole as primary treatment for the index proven or probable IA.

Study status

Finalised
Research institutions and networks

Institutions

Gilead Sciences
First published:
12/02/2024
Institution Pharmaceutical company

Contact details

Gilead Study Director

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable