Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China
NCT02336178
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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)
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China | |||
Official Title ICMJE | 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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | HEMOPHILIA B | |||
Intervention ICMJE | 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. | |||
Study Arms ICMJE | 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 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 70 | |||
Original Estimated Enrollment ICMJE | 68 | |||
Actual Study Completion Date ICMJE | August 2016 | |||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02336178 | |||
Other Study ID Numbers ICMJE | B1821052 2016-000765-22 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |