European chart review of avatrombopag in patients with ITP
Research type
Research Study
Full title
A European, multi-centre, retrospective, non-interventional study to describe real-world clinical outcomes, treatment patterns and healthcare resource use in patients treated with avatrombopag for primary immune thrombocytopenia (ITP) (AVA-EU)
IRAS ID
332939
Contact name
Quentin Hill
Contact email
Sponsor organisation
SOBI
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 11 months, 25 days
Research summary
This is a European, multi-centre, retrospective, non-interventional study. This study will be conducted in up to 22 centres across 7 countries (Spain, Italy, Germany, Czech Republic, United Kingdom (UK), Ireland and Belgium). There will be 3 health centres in the UK.
The study is based on retrospective collection of data from patients’ medical records. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required.
The population for this study is adult patients diagnosed with primary immune thrombocytopenia (ITP) who received treatment with avatrombopag (a type of drug called a thrombopoietin receptor agonist [or 'TPO-RA']), as part of their standard clinical care. The study is expected to recruit 75 patients with primary ITP in total: 50-55 patients who have never received a TPO-RA, and 20-25 patients who switched to avatrombopag from another TPO-RA.
The main aim of the study is to describe the treatment patterns and clinical outcomes of patients with primary ITP treated with avatrombopag (with and without previous treatment with another TPO-RA) to better understand the real-world effectiveness of the treatment.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0324
Date of REC Opinion
2 Nov 2023
REC opinion
Favourable Opinion