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Registry For Patients Treated With BeneFix In Usual Care Setting In Germany

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
Allgemeines Krankenhaus Linz, Kinderklinik
Linz, , 4020 Austria
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

- Patients with hemophilia B already receiving or starting treatment with reformulated
BeneFIX®.

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

- Patients with hemophilia B treated with a product other than BeneFIX®.

- Inclusion in the ongoing prospective registry of European hemophilia B patients using
BeneFIX®.

NCT00714415
Pfizer
Completed
Registry For Patients Treated With BeneFix In Usual Care Setting In Germany

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Descriptive Information
Brief TitleRegistry For Patients Treated With BeneFix In Usual Care Setting In Germany
Official TitlePharmacovigilance Evaluation Of Benefix (Registered) In Germany And Austria
Brief SummaryThe purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.
Detailed DescriptionNon-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPatients with hemophilia B
ConditionHemophilia B
InterventionDrug: BeneFIX
Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Study Groups/CohortsA
Patients with Hemophilia B
Intervention: Drug: BeneFIX
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: September 28, 2018)
80
Original Estimated Enrollment
 (submitted: July 11, 2008)
100
Actual Study Completion DateOctober 2016
Actual Primary Completion DateOctober 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.

Exclusion Criteria:

  • Patients with hemophilia B treated with a product other than BeneFIX®.
  • Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.
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 CountriesAustria,   Germany
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00714415
Other Study ID Numbers3090A1-4406
B1821011 ( Other Identifier: Alias Study Number )
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 2018

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]

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