Use of Bone Marrow Biopsies in Patients With Chronic Immune Thrombocytopenia: Predictors For, And Prognosis After – a Nordic Population-based Cohort Study And a Nested Case Control Study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39431
• EU PAS number:
  EUPAS33657
• Study ID:
  39431
• Official title and acronym:
  Use of Bone Marrow Biopsies in Patients With Chronic Immune Thrombocytopenia: Predictors For, And Prognosis After – a Nordic Population-based Cohort Study And a Nested Case Control Study
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Norway

  Sweden
• Study description:
  The study will characterize patients with chronic immune thrombocytopenia, including prevalence and incidence of biopsies, risk factors associated with biopsies, and outcomes among these patients.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Centre for Pharmacoepidemiology, Karolinska Institutet (CPE-KI)

Sweden

Study timelines

Date when funding contract was signed

Planned: 12/09/2019

Actual: 12/09/2019

Study start date

Planned: 25/02/2020

Actual: 25/02/2020

Data analysis start date

Planned: 26/02/2020

Actual: 26/02/2020

Date of final study report

Planned: 30/07/2020

Actual: 08/02/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen, Ltd

Study protocol

Initial protocol

01.02.06 Public Redacted Protocol Ver 1.0 2020-02-21 English

Regulatory

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