Study Evaluating Pharmacovigilance Of Refacto AF

Hemophilia A Clinical Trial

Official title:

Pharmacovigilance Evaluation Of Refacto Af (Registered) In Germany And Austria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895037
• Other study ID #: 3082B2-4420
• Secondary ID: B1831016
• Status: Completed
• Start date: July 17, 2009
• Est. completion date: October 19, 2016

Study information

• Verified date: September 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 19, 2016
• Est. primary completion date: October 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Austria	LKH - Univ. Klinikum Graz,Abt. fur Hamatologie	Graz
Austria	Allgemeines Krankenhaus Linz, Kinderklinik	Linz
Austria	Universitaetsklinik fuer Innere Medizin 1	Wien
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Klinikum Bremen Mitte	Bremen
Germany	Universitaetsklinikum Duesseldorf	Duesseldorf
Germany	Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie	Duesseldorf
Germany	CRC Coagulation Research Centre GmbH	Duisburg
Germany	Praxis zur Diagnostik und Therapie Von Blutgerinnungstoerungen	Frankfurt a. M.
Germany	Praxis fur Kinder- und Jugendmedizin	Grunwald
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Werlhof-Institut für Haemostaseologie GmbH	Hannover	Niedersachsen
Germany	SRH Kurpfalzkrankenhaus Heidelberg	Heidelberg
Germany	Donaustrasse 78	Memmingen
Germany	Praxis Dr. Autenrieth	Metzingen
Germany	Hämophilie-Zentrum Rhein Main GmbH	Mörfelden-Walldorf
Germany	Institut for Thrombophilia and Hemastaseologie	Muenster
Germany	Sonnengesundheitszentrum	München	Bayern
Germany	Stauferklinikum Schwaebisch Gmuend	Mutlangen
Germany	Universität Regensburg	Regensburg
Germany	Asklepios Fachklinikum Stadtroda GmbH	Stadtroda
Germany	Klinikum Stuttgart	Stuttgart
Germany	Universitaetsklinik fuer Kinder- und Jugendmedizin	Tuebingen
Germany	Stiftung Deutsche Klinik fur Diagnostik GmbH	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to last visit (up to 87 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.	Baseline until last visit (up to 87 months)
Primary	Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)	Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; cancer; congenital anomaly. AEs included both serious and non-serious adverse events. Relatedness of AEs with Refacto AF was assessed by the investigator.	Baseline until last visit (up to 87 months)
Primary	Number of Participants With Factor VIII (FVIII) Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay	FVIII inhibitor development was defined as measured inhibitor titer of greater than (>) 0.6 Bethesda Units (BU) using the Nijmegen-modified Bethesda assay.	Baseline until last visit (up to 87 months)
Primary	Mean Total Number of Bleeding Episodes in Participants	Participants documented all bleeding episodes in a diary during the study.	Baseline until last visit (up to 87 months)
Secondary	Mean Total Number of Bleeding Episodes Per Year in Participants	Participants documented all bleeding episodes in a diary during the study. Mean total number of bleeding episodes per year was calculated as: mean total number of bleeding episodes divided by duration of observation period (in years) for bleeding documentation.	Baseline until last visit (up to 87 months)
Secondary	Number of Participants With Change From Baseline Status in Days Missed From School or Work	Change from baseline status in days missed from school or work was categorized in 3 categories: Improvement, unchanged and worsening. Improvement defined as a decrease in number of days missed by participants from school/work as compared to baseline; worsening was defined as an increase in number of days missed by participants from school/work as compared to baseline; unchanged was defined as no change in number of days missed by participants from school/work as compared to baseline. In this outcome measure, number of participants with change from baseline status (as improved, worsen, unchanged) in days missed from school/work were reported.	Baseline until last visit (up to 87 months)
Secondary	Participant Assessment of Satisfaction With Treatment Handling	Participants evaluated their satisfaction with handing (administration) of Refacto AF and rated it in 4 categories as: very satisfied, satisfied, unsatisfied and very unsatisfied.	End of study visit (any time up to 87 months)
Secondary	Investigator Assessment of Treatment Satisfaction of Participants	Investigator assessed the treatment satisfaction of participants and categorized as very satisfied, satisfied, unsatisfied, or very unsatisfied.	End of study visit (any time up to 87 months)

External Links

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