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Study Evaluating Pharmacovigilance Of Refacto AF

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
LKH - Univ. Klinikum Graz,Abt. fur Hamatologie
Graz, , 8036 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
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 A of any severity already receiving or starting treatment
with ReFacto AF.

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

- Patients with Hemophilia A treated with a product other than Refacto AF.

NCT00895037
Pfizer
Completed
Study Evaluating Pharmacovigilance Of Refacto AF

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Descriptive Information
Brief TitleStudy Evaluating Pharmacovigilance Of Refacto AF
Official TitlePharmacovigilance Evaluation Of Refacto Af (Registered) In Germany And Austria
Brief SummaryThe purpose of this observational study is to describe the incidence of adverse events among patients treated with Refacto AF in usual health care settings in Germany and Austria.
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 A
ConditionHemophilia A
InterventionDrug: ReFacto AF (Moroctocog alfa)
Patients will be treated with intravenous infusion of ReFacto AF per dosing and frequency as prescribed by the subjects' treating physician. ReFacto AF® will be prescribed in the context of routine clinical practice in Germany and Austria, respectively
Study Groups/Cohorts1
Patients treated with Refacto AF
Intervention: Drug: ReFacto AF (Moroctocog alfa)
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: August 28, 2017)
101
Original Estimated Enrollment
 (submitted: May 5, 2009)
180
Actual Study Completion DateOctober 19, 2016
Actual Primary Completion DateOctober 19, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with hemophilia A of any severity already receiving or starting treatment with ReFacto AF.

Exclusion Criteria:

  • Patients with Hemophilia A treated with a product other than Refacto AF.
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 NumberNCT00895037
Other Study ID Numbers3082B2-4420
B1831016 ( 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 2017

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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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