Study Evaluating Pharmacovigilance Of Refacto AF

NCT00895037 | Completed Results

• 2 other identifiers: 3082B2-4420B1831016
• Study Type: observational
• Target: 101
• Locations: 2 countries
• Sites: 24

Brief 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.

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• Mean Total Number of Bleeding Episodes Per Year in Participants

  Baseline until last visit (up to 87 months)

• Number of Participants With Change From Baseline Status in Days Missed From School or Work

  Baseline until last visit (up to 87 months)

• Participant Assessment of Satisfaction With Treatment Handling

  End of study visit (any time up to 87 months)

• Investigator Assessment of Treatment Satisfaction of Participants

  End of study visit (any time up to 87 months)

Study Arms (1)

1

Patients treated with Refacto AF

Drug: ReFacto AF (Moroctocog alfa)

Interventions

ReFacto AF (Moroctocog alfa) DRUG

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

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hemophilia A

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (24)

LKH - Univ. Klinikum Graz,Abt. fur Hamatologie

Graz, 8036, Austria

Location

Allgemeines Krankenhaus Linz, Kinderklinik

Linz, 4020, Austria

Location

Universitaetsklinik fuer Innere Medizin 1

Vienna, 1090, Austria

Location

Sonnengesundheitszentrum

München, Bavaria, 80336, Germany

Location

Werlhof-Institut für Haemostaseologie GmbH

Hanover, Lower Saxony, 30159, Germany

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Klinikum Bremen Mitte

Bremen, 28205, Germany

Location

CRC Coagulation Research Centre GmbH

Duisburg, 47051, Germany

Location

Universitaetsklinikum Duesseldorf, Klinik f. Kinder-Onkologie, Haematologie u. Klinische Immunologie

Düsseldorf, 40225, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Praxis zur Diagnostik und Therapie Von Blutgerinnungstoerungen

Frankfurt A. M., 60596, Germany

Location

Praxis fur Kinder- und Jugendmedizin

Grünwald, 82031, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

SRH Kurpfalzkrankenhaus Heidelberg

Heidelberg, 69123, Germany

Location

Donaustrasse 78

Memmingen, 87700, Germany

Location

Praxis Dr. Autenrieth

Metzingen, 72555, Germany

Location

Hämophilie-Zentrum Rhein Main GmbH

Mörfelden-Walldorf, 64546, Germany

Location

Stauferklinikum Schwaebisch Gmuend

Mutlangen, 73557, Germany

Location

Institut for Thrombophilia and Hemastaseologie

Münster, 48143, Germany

Location

Universität Regensburg

Regensburg, 93042, Germany

Location

Asklepios Fachklinikum Stadtroda GmbH

Stadtroda, 07646, Germany

Location

Klinikum Stuttgart

Stuttgart, 70176, Germany

Location

Universitaetsklinik fuer Kinder- und Jugendmedizin

Tübingen, 72076, Germany

Location

Stiftung Deutsche Klinik fur Diagnostik GmbH

Wiesbaden, 65191, Germany

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII; recombinant factor VIII SQ

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Limitations and Caveats

Prioritization of outcome measures as primary and secondary was based on the study team's discretion, as it was not specified in source documents.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: May 7, 2009
• Study Start: July 17, 2009
• Primary Completion: October 19, 2016
• Study Completion: October 19, 2016
• Last Updated: July 17, 2018
• Results First Posted: July 17, 2018

Record last verified: 2017-09

Locations

AU (3); DE (21)