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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baxalta now part of Shire
Age
10–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
