A Post authorization safety surveillance registry with BeneFIX in hemophilia B patients in usual care settings

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26423
• EU PAS number:
  EUPAS5890
• Study ID:
  26423
• Official title and acronym:
  A Post authorization safety surveillance registry with BeneFIX in hemophilia B patients in usual care settings
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  This is a non-interventional,voluntary prospective registry study conducted in major hemophilia treatment centers in China. The objective of this registry is to evaluate the safety and efficacy of BeneFIX in hemophilia B patients in the Chinese population. It will enroll Chinese patients with Hemophilia B of all severities. Enrolled subjects will be treated with intravenous infusions of BeneFIX at a dose and frequency prescribed by the subject’s treating physician in accordance with the BeneFIX label and will be adjusted solely according to medical and therapeutic necessity. The registry study will capture observations that will be used for evaluating recombinant FIX replacement product safety, including: subject demographics, medical history, hemophilia history and medications. Safety assessments, treatment data and any laboratory-based FIX inhibitor determinations will be collected at all visits. All subjects in this registry will be followed for 1 year.
• Study status:
  Finalised

Research institutions and networks

Institutions

Institute of Hematology and Hospital of Blood Diseases, Chinese Academy of Medical Sciences

Multiple centres: 16 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 16/01/2013

Actual: 15/01/2015

Study start date

Planned: 16/08/2014

Actual: 23/01/2015

Data analysis start date

Planned: 29/08/2016

Actual: 13/10/2015

Date of interim report, if expected

Planned: 27/01/2015

Actual: 10/03/2016

Date of final study report

Planned: 12/12/2016

Actual: 19/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

A Post authorization safety surveillance registry with BeneFIX in hemophilia B patients in usual care settings

Updated protocol

Administrative Amendment

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)