Brief Title
Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China
Official Title
An Open-label, Single-arm, Post-authorization Pragmatic Clinical Trial On The Safety And Efficacy Of Benefix (Nonacog Alfa, Recombinant Factor Ix) In Subjects With Hemophilia B In Usual Care Settings In China
Brief Summary
The purpose of this post-approval study is to evaluate the safety and efficacy of Benefix in subjects with hemophilia B in usual care settings in China.
Detailed Description
The purpose of this post-approval study is to provide supplementary information relating to the use of BeneFIX in Chinese subjects with hemophilia B, especially on the safety and efficacy in different populations of Chinese hemophilia B patients, in particular in pediatric patients <6 years of age, pediatric patients ≥6 to ≤12 years of age, Previously Untreated Patients (PUPs) , subjects receiving prophylaxis treatment after enrollment in the study, and severe patients (FIX activity <1%).
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of Participants Who Developed Factor IX Inhibitor
Secondary Outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Condition
HEMOPHILIA B
Intervention
Benefix
Study Arms / Comparison Groups
Benefix
Description: This is a single arm study. Subjects will be treated with Benefix by the investigator according to usual care in China and in accord with the China BeneFIX Package Insert.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
70
Start Date
January 2015
Completion Date
August 2016
Primary Completion Date
July 2016
Eligibility Criteria
Inclusion Criteria: - Male and/or female subjects with hemophilia B. - Subjects/parents/legal representatives must be able to comply with study procedures (informed consent/assent process, clinical visits, reporting of infusion and bleed data, reporting of adverse events, etc) Exclusion Criteria: - Presence of any other bleeding disorder in addition to hemophilia B. Subjects with a past history of, or current factor IX inhibitor. For laboratory-based assessments, any Bethesda inhibitor titer greater than the laboratory's normal range or ≥0.6 Bethesda Unit (BU)/mL. - Subjects with known hypersensitivity to the active substance or to any of the excipients of BeneFIX. - Subjects with a known hypersensitivity to Chinese Hamster Ovary cell proteins.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02336178
Organization ID
B1821052
Secondary IDs
2016-000765-22
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
March 2017