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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105892
• 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 is a real-world, non-interventional, multi-country, retrospective chart review study using patient medical record data collected from 16 hospitals in 5 European countries (Belgium, France, Germany, Spain, and the United Kingdom UK). This is 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 will be included in the study. The primary objective of this study is 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:
  Ongoing

Research institutions and networks

Institutions

Gilead Sciences

Study timelines

Date when funding contract was signed

Actual: 22/12/2022

Study start date

Planned: 22/05/2023

Actual: 27/06/2023

Date of final study report

Planned: 28/02/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences

Study protocol

Initial protocol

GS-EU-131-6385 - appendix-16.1.-protocol_f-redact_reduced

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable