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Post Marketing Observational Study of Reformulated BeneFIX

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chamberry, Cedex, 73011 France
Contact
1-800-718-1021
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

- Subjects with Hemophilia B already receiving or starting treatment with reformulated
BeneFIX.

- Subjects who have dated and signed the informed consent form.

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

- Ongoing treatment of Hemophilia B by a product other than reformulated BeneFIX.

- Participation in the European prospective registry of patients with Hemophilia B
treated with BeneFIX (Wyeth protocol 3090A-101039).

NCT00835068
Pfizer
Completed
Post Marketing Observational Study of Reformulated BeneFIX

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Post Marketing Observational Study of Reformulated BeneFIX
Post Marketing Observational Study Of Reformulated BeneFIX
The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.
No sampling
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Hemophilia B patients already receiving or starting treatment with reformulated BeneFIX
Hemophilia B
Other: No intervention
As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician
BeneFIX
Intervention: Other: No intervention
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX.
  • Subjects who have dated and signed the informed consent form.

Exclusion Criteria:

  • Ongoing treatment of Hemophilia B by a product other than reformulated BeneFIX.
  • Participation in the European prospective registry of patients with Hemophilia B treated with BeneFIX (Wyeth protocol 3090A-101039).
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00835068
3090X1-4409
B1821007
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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