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Study Evaluating Refacto For Pharmacovigilance

Last updated on October 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Vienna, , A-1090 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Male
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

- Proven diagnosis of Hemophilia A

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

- Contraindications according to Summary of Product Characteristics

NCT00195442
Pfizer
Completed
Study Evaluating Refacto For Pharmacovigilance

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Descriptive Information
Brief TitleStudy Evaluating Refacto For Pharmacovigilance
Official TitlePharmacovigilance Evaluation Of Refacto In Usual Care Settings
Brief SummaryThe purpose of this study is to investigate the effectiveness and safety of treatment with ReFacto under conditions of routine therapy. Furthermore a continuous benefit/risk assessment will be done.
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: Moroctocog alfa
Patients will be treated in accordance with the requirements of the labeling of ReFacto (Moroctocog alfa) in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Other Name: ReFacto
Study Groups/CohortsA
Patients with Hemophilia A
Intervention: Drug: 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: December 22, 2010)
288
Original Enrollment
 (submitted: September 13, 2005)
150
Actual Study Completion DateJanuary 2010
Actual Primary Completion DateJanuary 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Proven diagnosis of Hemophilia A

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristics
Sex/Gender
Sexes Eligible for Study:Male
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 NumberNCT00195442
Other Study ID Numbers3082A-100690
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateFebruary 2011

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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