Study identification

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

Contact details

Pablo Rendo

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

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

More details on funding

Pfizer
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)