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

NCT00093210

Last updated date
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Hemophilia BPost Marketing Observational Study of Reformulated BeneFIX
NCT00835068
  1. Chamberry, Cedex
  2. Le Chesnay, Cedex
  3. Caen Cedex 9,
  4. Clermont Ferrand,
  5. Dijon Cedex,
  6. leKremlin-Bicetre,
  7. Lyon,
  8. Marseille Cedex 05,
  9. Montmorency,
  10. Montpellier Cedex 5,
  11. Nantes cedex 1,
  12. Paris,
  13. Paris,
  14. Rouen,
  15. Saint Priest en Jarez,
  16. Tours,
  17. Vandoeuvre Les Nancy Cedex,
ALL GENDERS
0+
years
MULTIPLE SITES
Hemophilia BStudy Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B
NCT00364182
  1. Phoenix, Arizona
  2. Chicago, Illinois
  3. Chicago, Illinois
  4. New Brunswick, New Jersey
  5. Houston, Texas
  6. Edmonton, Alberta
  7. Edmonton, Alberta
  8. Ottawa, Ontario
  9. Zagreb,
  10. Budapest,
  11. Castelfranco Veneto (TV),
  12. Coppito (AQ),
  13. Bucuresti,
  14. Moscow,
  15. Saint Petersburg,
  16. Belgrade,
  17. Nis,
  18. Madrid,
  19. Sevilla,
Male
6 Years+
years
MULTIPLE SITES
Hemophilia BStudy Evaluating rFIX; BeneFIX® in Hemophilia B
NCT00093171
  1. Los Angeles, California
  2. Aurora, Colorado
  3. Detroit, Michigan
  4. New Brunswick, New Jersey
  5. Chapel Hill, North Carolina
  6. Dayton, Ohio
  7. Houston, Texas
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Hemophilia BBeneFIX Drug Use Results Survey [All-Case Surveillance]
NCT01154231
  1. Shinjuku-ku, Tokyo
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Condition  ICMJE Hemophilia B
Intervention  ICMJE
  • Drug: rFIX
  • Drug: rFIX-R
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00093210
Other Study ID Numbers  ICMJE 3090A1-304
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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