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Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Guangzhou, Guangzhou, 510515 China
Contact
1-800-718-1021
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
6+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- Diagnosed with any bleeding disorder in addition to hemophilia B

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

- Subject has no history of exposure to FIX products (previously untreated patient
[PUP])

- 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

- 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

NCT00866606
Pfizer
Completed
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

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Similar Trials

Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B
This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemophilia B
Biological: Benefix
BeneFIX for on-demand treatment of bleeding episodes were according to investigator prescription. FIX recovery was assessed by determining the FIX activity (FIX:C) levels in individual subjects. BeneFIX dosage for recovery assessments: single 75 IU/kg (±5 IU/kg) IV bolus infusion.
Experimental: Benefix
Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.
Intervention: Biological: Benefix
Yang R, Zhao Y, Wang X, Sun J, Jin J, Wu D, Charnigo R, O'Brien A, Zhong Z, Rendo P. Evaluation of the safety and efficacy of recombinant factor IX (nonacog alfa) in minimally treated and previously treated Chinese patients with haemophilia B. Haemophilia. 2012 Sep;18(5):e374-8. doi: 10.1111/j.1365-2516.2012.02907.x. Epub 2012 Jul 9.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
December 2009
December 2009   (Final data collection date for primary outcome measure)

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 laboratory)
  • Subject has no history of exposure to FIX products (previously untreated patient [PUP])
  • 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
Sexes Eligible for Study: All
6 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00866606
3090A1-3305
B1821004
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2011

ICMJE     Data element required by the

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

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1-800-718-1021

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