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Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemophilia B

Intervention: Benefix (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.

Clinical Details

Official title: An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion

Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion

Percentage of Participants With FIX Inhibitor Development

Secondary outcome:

Number of Infusions Required to Treat Each Bleed

FIX Incremental Recovery

Percentage of Participants With Less Than Expected Therapeutic Effect (LETE)

Percentage of Participants With Allergic-Type Allergic Reactions

Percentage of Participants With Thrombosis

Percentage of Participants With Red Blood Cell (RBC) Agglutination


Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B

(FIX activity: more than 5%, 1-5%, or less than 1%, respectively)

- Subjects with previous exposure to FIX replacement therapy

- If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry

Exclusion Criteria:

- Diagnosed with any bleeding disorder in addition to hemophilia B

- Current FIX inhibitor or history of FIX inhibitor (defined as >ULN of the reporting


- Subject has no history of exposure to FIX products (previously untreated patient


- Subject is currently utilizing primary FIX prophylaxis

- Subjects anticipating elective surgery that may be planned to occur in the 6 months

following study entry

- Treated with immunomodulatory therapy within 30 days prior to study entry or planned

use for the duration of their study participation

- Participated in another investigational drug or device study within 30 days prior to

study entry or planned participation for the duration of their study participation

- Subjects with a known hypersensitivity to hamster protein

- Significant hepatic or renal impairment (ALT and AST >5 x ULN, bilirubin >2 mg/dL or

serum creatinine >1. 25 x ULN)

- Prothrombin Time >1. 5 x ULN

- Platelet count <80,000/µL

- Pregnant or breastfeeding women

- Unwilling or unable to follow the terms of the protocol

- Any condition which may compromise the subject's ability to comply with and/or

perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor

Locations and Contacts

Pfizer Investigational Site, Beijing 100730, China

Pfizer Investigational Site, Shanghai 200025, China

Pfizer Investigational Site, Guangzhou, Guangzhou 510515, China

Pfizer Investigational Site, Suzhou, Jiangsu 215006, China

Pfizer Investigational Site, Tianjin, Tianjin 300020, China

Pfizer Investigational Site, Hangzhou, Zhejiang 310003, China

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: February 2009
Last updated: April 1, 2011

Page last updated: August 20, 2015

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