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Study Evaluating rFIX; BeneFIX® in Hemophilia B

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NCT00093171

Last updated on May 12, 2018
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FOR MORE INFORMATION
Study Location
Los Angeles, California, 90027 United States
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
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Hemophilia B (FIX:C less than 2%)

- Previous treatment of at least 150 exposure days using any FIX product

- 12 years of age and older

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

- The patient has a currently detectable factor IX inhibitor or a history of inhibitors.
(A family history of inhibitors will not exclude the patient)

- Known hypersensitivity to protein pharmaceuticals or agents related to the test
article, e.g. hamster proteins

- Patient has a genetic coagulation disorder other than hemophilia B

NCT00093171
Pfizer
Completed
Study Evaluating rFIX; BeneFIX® in Hemophilia B

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Study Evaluating rFIX; BeneFIX® in Hemophilia B
An Open-label Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Previously Treated Patients (PTPs) With Hemophilia B (FIX:C ?2%)
The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ?2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Hemophilia B
Drug: rFIX
Not Provided
Rendo P, Smith L, Lee HY, Shafer F. Nonacog alfa: an analysis of safety data from six prospective clinical studies in different patient populations with haemophilia B treated with different therapeutic modalities. Blood Coagul Fibrinolysis. 2015 Dec;26(8):912-8. doi: 10.1097/MBC.0000000000000359.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
May 2005
May 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hemophilia B (FIX:C less than 2%)
  • Previous treatment of at least 150 exposure days using any FIX product
  • 12 years of age and older

Exclusion Criteria:

  • The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient)
  • Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins
  • Patient has a genetic coagulation disorder other than hemophilia B
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00093171
3090A1-302
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

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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