Study identification

PURI

https://redirect.ema.europa.eu/resource/45344

EU PAS number

EUPAS34701

Study ID

45344

Official title and acronym

Nordic Country Patient Registry for Romiplostim (NCPRR): Population-Based Prospective Annual Assessment of Safety of Romiplostim Treatment in Adult Patients with Chronic Idiopathic (Immune) Thrombocytopenic Purpura (ITP) Based on National Health Registry Systems in Denmark, Sweden and Norway (20070797)

DARWIN EU® study

No

Study countries

Denmark
Norway
Sweden

Study description

The study is a European Medicines Agency (EMA) mandated category 3 Post Authorization Safety Study (PASS) investigating the long-term safety of Nplate® (romiplostim) in the treatment of adults diagnosed with chronic immune thrombocytopenia (cITP). The primary objective addresses possible changes in bone marrow, and the secondary objectives address a number of other specific postulated safety endpoints. The study is a retrospective observational study which takes the form of a registry encompassing the vast majority of adult cITP patients in Denmark, Norway, and Sweden over the period 2009 to 2019. Data is primarily extracted from patient medical notes, with some elements obtained through linkage to National Health Registry Systems (NHRS) in each country. The study is wholly undertaken on behalf of Amgen by Aarhus University, Denmark, with key collaborators in each country. The investigators are responsible of the collection of data, its management, and its analysis: the Aarhus University team are then responsible for interpretation of the cumulative data in an annual report which is submitted to the EMA. There is a two-year lag between data collection and production of the report: the final report, encompassing analysis of the full 2009-2019 dataset, will be submitted to the EMA in 2021. Independent oversight of the study is provided by a Scientific Advisory Committee (SAC) whose members are Key Opinion Leaders (KOLs) in Denmark, Finland, Norway, and Sweden.

Study status

Finalised
Research institution and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
Department of Clinical Epidemiology, Aarhus University Hospital Olof Palmes Allé 43-45. 8200 Aarhus N

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Start date of data analysis

Planned:
Actual:

Date of final study report

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

More details on funding

Amgen
Study protocol
Initial protocol

EUPAS34701-35135

English (731.5 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)