Post Marketing Observational Study of Reformulated BeneFIX

NCT00835068

Last updated date
Study Location
Pfizer Investigational Site
Chamberry, Cedex, 73011, France
Contact
1-800-718-1021

FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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).

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[email protected]

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Advanced Information
Descriptive Information
Brief Title Post Marketing Observational Study of Reformulated BeneFIX
Official Title Post Marketing Observational Study Of Reformulated BeneFIX
Brief Summary 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.
Detailed Description No sampling
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 Hemophilia B patients already receiving or starting treatment with reformulated BeneFIX
Condition Hemophilia B
Intervention Other: No intervention
As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician
Study Groups/Cohorts BeneFIX
Intervention: Other: No intervention
Publications * Not Provided

*   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: December 12, 2013)
58
Original Estimated Enrollment
 (submitted: February 2, 2009)
60
Actual Study Completion Date October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
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 France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00835068
Other Study ID Numbers 3090X1-4409
B1821007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2014