Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use

NCT00167973

Last updated date
Study Location
Vienna, , 1090, Austria
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
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment

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

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 Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use
Official Title A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use
Brief Summary This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All EU patients beginning treatment with BeneFIX
Condition Hemophilia B
Intervention Not Provided
Study Groups/Cohorts 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 Completed
Actual Enrollment
 (submitted: May 25, 2010)
218
Original Enrollment
 (submitted: September 11, 2005)
175
Actual Study Completion Date June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   France,   Germany,   Italy,   Netherlands,   Portugal,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00167973
Other Study ID Numbers 3090A-101039
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial mANAGERFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
Principal Investigator:Trial ManagerFor Sweden, [email protected]
Principal Investigator:Trial ManagerFor Austria, [email protected]
Principal Investigator:Trial ManagerFor UK, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date May 2010