Post Authorization Rixubis Study (PARIXS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/13806
• EU PAS number:
  EUPAS9847
• Study ID:
  13806
• Official title and acronym:
  Post Authorization Rixubis Study (PARIXS)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The study addresses the description of routine clinical practice with a new rFIX product (RIXUBIS) usingany therapeutic regimen administered to hemophilia B patients.This post-authorization, prospective, uncontrolled, observational, open-label, non-interventional,multicenter cohort study is designed to measure short and long-term outcomes in terms of effectiveness,safety, joint health, quality of life and economic outcomes in routine clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Hannover Medical School (MHH)

Multiple centres: 5 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 20/01/2015

Actual: 20/01/2015

Study start date

Planned: 30/04/2015

Actual: 16/09/2015

Data analysis start date

Planned: 01/04/2022

Actual: 12/04/2016

Date of final study report

Planned: 30/06/2022

Actual: 10/06/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxalta

Study protocol

Initial protocol

251401-protocol-2015mar20

Regulatory

• Was the study required by a regulatory body?:
  No