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Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B

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NCT00093210

Last updated on October 5, 2018
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FOR MORE INFORMATION
Study Location
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

- Moderate to severe hemophilia B (FIX: C ≤2%)

- Previously treated patients (PTPs) with ≥150 documented exposure days

- Age ≥ 12 years (US sites only)

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

- Detectable factor IX inhibitor defined as ?0.6 Bethesda Units for pooled plasma
reported by the local laboratory (family history of inhibitors will not exclude the
patient)

- Patient history of factor IX inhibitor replacement therapy

- Patient unable to be off factor IX replacement therapy for at least 5 days without
bleeding

NCT00093210
Pfizer
Completed
Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B

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Pfizer Clinical Trials Contact Center

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[email protected]

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Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B
A Double-Blind, Randomized, Crossover Evaluation of the Pharmacokinetics of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R); and an Open-Label Safety and Efficacy Evaluation of rFIX-R in Previously Treated Patients With Moderate to Severe (FIX:C?2%) Hemophilia B
The primary objective of this clinical research study is to establish the bioequivalence of 2 treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Hemophilia B
  • Drug: rFIX
  • Drug: rFIX-R
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
Not Provided
September 2005
Not Provided

Inclusion Criteria:

  • Moderate to severe hemophilia B (FIX: C ?2%)
  • Previously treated patients (PTPs) with ?150 documented exposure days
  • Age ? 12 years (US sites only)

Exclusion Criteria:

  • Detectable factor IX inhibitor defined as ?0.6 Bethesda Units for pooled plasma reported by the local laboratory (family history of inhibitors will not exclude the patient)
  • Patient history of factor IX inhibitor replacement therapy
  • Patient unable to be off factor IX replacement therapy for at least 5 days without bleeding
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00093210
3090A1-304
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
December 2007

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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