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
NCT ID: NCT00157053
Last Updated: 2021-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
82 participants
INTERVENTIONAL
2001-11-22
2004-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Antihemophilic factor, recombinant, manufactured protein-free
Eligibility Criteria
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Inclusion Criteria
* 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 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
10 Years
MALE
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Mountain States Regional Hemophilia and Thrombosis Center
Aurora, Colorado, United States
Childrens Healthcare of Atlanta Blood Bank
Atlanta, Georgia, United States
Comprehensive Bleeding Disorders Center
Peoria, Illinois, United States
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States
Michigan State University
East Lansing, Michigan, 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
Children's Hospital Medical Center Pharmacy
Cincinnati, Ohio, United States
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, United States
Puget Sound Blood Center
Seattle, Washington, United States
Allgemeines Krankenhaus der Stadt Wien
Vienna, , Austria
KU Leuven Universitaire Ziekenhuizen
Leuven, , Belgium
University of Alberta
Calgary, Alberta, Canada
Hôpital Edouard Herriot
Lyon, , France
Klinikum der J. W. Goethe - Universität
Frankfurt am Main, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum Innenstadt der Universität München
Munich, , Germany
Ospedale Maggiore di Milano
Milan, , Italy
University Hospital MAS
Malmo, , Sweden
The Royal Free Hospital
London, England, United Kingdom
Central Manchester Healthcare NHS Trust
Manchester, England, United Kingdom
The Churchill Hospital
Oxford, England, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Countries
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References
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Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392.
Other Identifiers
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060102
Identifier Type: -
Identifier Source: org_study_id
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