Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901

Hemophilia A Clinical Trial

Official title:

Evaluation of Pharmacokinetics, Safety, Efficacy and Immunogenicity of rAHF-PFM in Previously Treated Hemophilia A Patients - A Continuation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157053
• Other study ID #: 060102
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 22, 2001
• Est. completion date: August 3, 2004

Study information

• Verified date: August 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxter Study 069901.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 3, 2004
• Est. primary completion date: August 3, 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Subject has completed Baxter protocol 069901

• Subject is HIV-1 seronegative or, if HIV-1 seropositive, has a CD4+ lymphocyte count >= 400/mm3 documented within three months of the screening visit

• Subject (and his legally acceptable representative, in the case of study participants >= 10 and < 18 years of age) has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate IRB/IEC and Baxter

Exclusion Criteria:

• The subject received factor VIII products other than rAHF-PFM upon completion of Baxter protocol 069901

• The subject developed an inhibitor to factor VIII, measured in the central laboratory, during Baxter protocol 069901. An inhibitor is defined as a Bethesda titer > 1.0 or, if Bethesda titer < 1.0, confirmation using the Nijmegen modification of the Bethesda assay with a titer > 0.6

• The subject is scheduled to receive an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, steroids) during the course of the study

• The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Drug:
• Antihemophilic factor, recombinant, manufactured protein-free

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus der Stadt Wien	Vienna
Belgium	KU Leuven Universitaire Ziekenhuizen	Leuven
Canada	University of Alberta	Calgary	Alberta
France	Hôpital Edouard Herriot	Lyon
Germany	Klinikum der J. W. Goethe - Universität	Frankfurt am Main
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Klinikum Innenstadt der Universität München	Munich
Italy	Ospedale Maggiore di Milano	Milan
Sweden	University Hospital MAS	Malmö
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	The Royal Free Hospital	London	England
United Kingdom	Central Manchester Healthcare NHS Trust	Manchester	England
United Kingdom	The Churchill Hospital	Oxford	England
United States	Childrens Healthcare of Atlanta Blood Bank	Atlanta	Georgia
United States	Mountain States Regional Hemophilia and Thrombosis Center	Aurora	Colorado
United States	Children's Hospital Medical Center Pharmacy	Cincinnati	Ohio
United States	Michigan State University	East Lansing	Michigan
United States	Indiana Hemophilia & Thrombosis Center	Indianapolis	Indiana
United States	University of Medicine & Dentistry of New Jersey	New Brunswick	New Jersey
United States	Cornell Medical Center	New York	New York
United States	Mt. Sinai Medical School	New York	New York
United States	Comprehensive Bleeding Disorders Center	Peoria	Illinois
United States	Hemophilia Center of Western Pennsylvania	Pittsburgh	Pennsylvania
United States	Puget Sound Blood Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Terminal phase half-life for Recombinant Antihemophilic Factor (rAHF-PFM)		Within 30 minutes prior to the pharmacokinetic infusion and at 1 hour ± 5 minutes, 9 ± 1 hour, 24 ± 2 hours, and 48 ± 2 hours after the infusion.