Study Evaluating Refacto For Pharmacovigilance

NCT00195442 | Completed Results

• 1 other identifier: 3082A-100690
• Study Type: observational
• Target: 288
• Locations: 2 countries
• Sites: 26

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.

Conditions

Hemophilia A

Keywords

Hemophilia A

Outcome Measures

Primary Outcomes (3)

• Mean Number of Bleeding Episodes Per Patient Year

  Participants with hemophilia A suffer from a hereditary lack of blood clotting factor VIII. As a consequence, the ability of the blood to coagulate is reduced and bleedings at any site or organ of the body may occur after minor injury or even spontaneously. Predominantly, joints, muscles, and internal organs are affected by bleeding complications. Participants reported the occurrence of each bleeding episode while on study. The bleeding rate for each participant was calculated by number of reported episodes per years on study.

  Baseline up to a mean duration of 54 months

• Mean Number of Bleeding-related Exposure Days Per Patient Year

  Exposure days are the number of days of treatment with ReFacto.

  Baseline up to a mean duration of 54 months

• Mean Number of Exposure Days Per Patient Year

  Exposure days are the number of days of treatment with ReFacto.

  Baseline up to a mean duration of 54 months

Secondary Outcomes (11)

• Number of Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to a mean duration of 54 months

• Number of Participants With de Novo Inhibitor Formation

  Baseline up to a mean duration of 54 months

• Mean Annual ReFacto Consumption Per Patient Year

  Baseline up to a mean duration of 54 months

• Number of Participants for Physicians' Assessment of Satisfaction With Treatment Success

  Baseline up to a mean duration of 54 months

• Number of Participants for Physicians' Assessment of Efficacy

  Baseline up to a mean duration of 54 months

Study Arms (1)

A

Patients with Hemophilia A

Drug: Moroctocog alfa

Interventions

Moroctocog alfa DRUG

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.

Also known as: ReFacto

A

Eligibility Criteria

• Sex: male
• 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:

• Proven diagnosis of Hemophilia A

You may not qualify if:

• Contraindications according to Summary of Product Characteristics

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (26)

Pfizer Investigational Site

Vienna, Vienna, A-1090, Austria

Location

Pfizer Investigational Site

Berlin, Germany, 10249, Germany

Location

Pfizer Investigational Site

Wiesbaden, Germany, 65191, Germany

Location

Pfizer Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

Location

Pfizer Investigational Site

Giessen, Hesse, 35385, Germany

Location

Pfizer Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

Pfizer Investigational Site

Rostock, Mecklenburg-Vorpommern, 18055, Germany

Location

Pfizer Investigational Site

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Pfizer Investigational Site

Halle, Saxony-Anhalt, 06120, Germany

Location

Pfizer Investigational Site

Stadtroda, Thuringia, 07646, Germany

Location

Pfizer Investigational Site

Berlin, 13353, Germany

Location

Pfizer Investigational Site

Bermen, 28205, Germany

Location

Pfizer Investigational Site

Erlangen, 91054, Germany

Location

Pfizer Investigational Site

Frankfurt A. M., 60594, Germany

Location

Pfizer Investigational Site

Hamburg, 20246, Germany

Location

Pfizer Investigational Site

Heidelberg, 69123, Germany

Location

Pfizer Investigational Site

Homburg, 66424, Germany

Location

Pfizer Investigational Site

Klipphausen, 01665, Germany

Location

Pfizer Investigational Site

Leipzig, 04103, Germany

Location

Pfizer Investigational Site

Lübeck, 23538, Germany

Location

Pfizer Investigational Site

München, 80336, Germany

Location

Pfizer Investigational Site

München, 80337, Germany

Location

Pfizer Investigational Site

Münster, D-48143, Germany

Location

Pfizer Investigational Site

Potsdam, 14467, Germany

Location

Pfizer Investigational Site

Schwerin, 19049, Germany

Location

Pfizer Investigational Site

Ulm, 89081, Germany

Location

Related Links

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

MeSH Terms

Conditions

Hemophilia A

Interventions

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

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

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: July 1, 1999
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 11, 2011
• Results First Posted: February 7, 2011

Record last verified: 2011-02

Locations

AU (1); DE (25)