Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000315

EU PAS number

EUPAS1000000315

Study ID

1000000315

Official title and acronym

Postauthorisation Safety Study (PASS) of Avatrombopag and Haematological Malignancies in Patients With Primary Immune Thrombocytopaenia

DARWIN EU® study

No

Study countries

Denmark
Sweden

Study description

Avatrombopag maleate (Doptelet®) is an orally administered thrombopoietin receptor agonist (TPO-RA) approved by the European Medicines Agency (EMA) for the treatment of primary immune thrombocytopaenia (ITP) in adults. It is also approved as second-line treatment. This postauthorisation safety study (PASS) will provide a descriptive analysis of haematological malignancies among patients exposed to avatrombopag using the Danish National Health Registers and the Swedish National Health Registers. This non-interventional, population-based, descriptive cohort study will use secondary data collection to estimate the incidence rate (IR) of haematological malignancies among patients with primary ITP who initiate avatrombopag. To contextualise this IR, the IR of haematological malignancies will also be estimated among patients with ITP who have not received avatrombopag. Finally, a standardised morbidity ratio will also be estimated.

Study status

Planned
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
InstitutionNot-for-profitENCePP partner

Contact details

Maria Foraster

Primary lead investigator
ORCID number:
0000-0003-4450-4123
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Swedish Orphan Biovitrum AB (publ)
Study protocol
Initial protocol

5735_ITP PASS Protocol_v1.2_Final_20Dec2023_Redacted.pdf

English (883.6 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)