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Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China

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NCT02336178

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515 China
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HEMOPHILIA B
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02336178
Pfizer
Completed
Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China

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[email protected]

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Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China
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
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.
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%).
Interventional
Phase 4
Masking: None (Open Label)
Primary Purpose: Treatment
HEMOPHILIA B
Drug: Benefix

Subjects will be treated by the investigator according to usual care in China and in accord with the China BeneFIX Package Insert.

The treatment duration is approximately 6 months (±7 days) or approximately 50 Exposure Days (EDs) (±5 EDs) (see protocol definition on EDs) whichever occurs first.
Experimental: Benefix
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.
Intervention: Drug: Benefix
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
August 2016
July 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT02336178
B1821052
2016-000765-22 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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