Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

NCT00866606

Last updated date
Study Location
Pfizer Investigational Site
Guangzhou, Guangzhou, 510515, China
Contact
1-800-718-1021

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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 <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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
Official Title  ICMJE An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B
Brief Summary This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemophilia B
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Benefix
Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.
Intervention: Biological: Benefix
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2010)
35
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2009)
30
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years and older   (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 NCT00866606
Other Study ID Numbers  ICMJE 3090A1-3305
B1821004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP