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Post Marketing Observational Study of Reformulated BeneFIX

Last updated on October 14, 2019

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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Descriptive Information
Brief TitlePost Marketing Observational Study of Reformulated BeneFIX
Official TitlePost Marketing Observational Study Of Reformulated BeneFIX
Brief SummaryThe 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 DescriptionNo sampling
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationHemophilia B patients already receiving or starting treatment with reformulated BeneFIX
ConditionHemophilia B
InterventionOther: No intervention
As it is a non interventional study, patient receives his usual treatment (BeneFIX) as determined by the physician
Study Groups/CohortsBeneFIX
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 StatusCompleted
Actual Enrollment
 (submitted: December 12, 2013)
58
Original Estimated Enrollment
 (submitted: February 2, 2009)
60
Actual Study Completion DateOctober 2013
Actual Primary Completion DateOctober 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesFrance
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00835068
Other Study ID Numbers3090X1-4409
B1821007
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2014

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