Clinical trial NCT00195442: Study Evaluating Refacto For Pharmacovigilance
Official title: Pharmacovigilance Evaluation Of Refacto In Usual Care Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: Hemophilia A
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 288
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hemophilia A

Brief summary: The 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 description: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria: Inclusion Criteria:

* Proven diagnosis of Hemophilia A

Exclusion Criteria:

* Contraindications according to Summary of Product Characteristics

Primary outcomes:
measure: Mean Number of Bleeding Episodes Per Patient Year
timeFrame: Baseline up to a mean duration of 54 months
measure: Mean Number of Bleeding-related Exposure Days Per Patient Year
timeFrame: Baseline up to a mean duration of 54 months
measure: Mean Number of Exposure Days Per Patient Year
timeFrame: Baseline up to a mean duration of 54 months
Secondary outcomes:
measure: Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to a mean duration of 54 months
measure: Number of Participants With de Novo Inhibitor Formation
timeFrame: Baseline up to a mean duration of 54 months
measure: Mean Annual ReFacto Consumption Per Patient Year
timeFrame: Baseline up to a mean duration of 54 months
measure: Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success
timeFrame: Baseline up to a mean duration of 54 months
measure: Number of Participants for Physicians' Assessment of Efficacy
timeFrame: Baseline up to a mean duration of 54 months
measure: Number of Participants for Patients' Assessment of Efficacy
timeFrame: Baseline up to a mean duration of 54 months
measure: Number of Participants for Physicians' Assessment of Tolerance
timeFrame: Baseline up to a mean duration of 54 months
measure: Number of Participants for Patients' Assessment of Tolerance
timeFrame: Baseline up to a mean duration of 54 months
measure: Number of Participants for Physicians' Assessment of Handling of ReFacto
timeFrame: Baseline up to a mean duration of 54 months
measure: Number of Participants for Patients' Assessment of Handling of ReFacto
timeFrame: Baseline up to a mean duration of 54 months
measure: Number of Participants for Days of Sick Leave Per Month
timeFrame: Baseline up to a mean duration of 54 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
state: Hessen
city: Giessen
country: Germany
facility: Pfizer Investigational Site
state: Hessen
city: Rostock
country: Germany
facility: Pfizer Investigational Site
state: Mecklenburg-Vorpommern
city: Hannover
country: Germany
facility: Pfizer Investigational Site
state: Niedersachsen
city: Bonn
country: Germany
facility: Pfizer Investigational Site
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: Pfizer Investigational Site
state: Sachsen-Anhalt
city: Stadtroda
country: Germany
facility: Pfizer Investigational Site
state: Thuringen
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bermen
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt a. M.
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Heidelberg
country: Germany
facility: Pfizer Investigational Site
city: Homburg
country: Germany
facility: Pfizer Investigational Site
city: Klipphausen
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Lubeck
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Potsdam
country: Germany
facility: Pfizer Investigational Site
city: Schwerin
country: Germany
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: