Status:
COMPLETED
Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A
Lead Sponsor:
Grifols Biologicals, LLC
Conditions:
Severe Hemophilia A
Eligibility:
MALE
6-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the immunologic and overall safety associated with long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less than 0.01 IU/...
Detailed Description
This is a Phase IV, non-randomized, multicenter study of at least 50 evaluable subjects diagnosed with severe hemophilia A. Enrolled subjects will be treated at home and with in-clinic therapy exclusi...
Eligibility Criteria
Inclusion
- Male.
- At least 6 years of age and not more than 65 years of age.
- Signed and dated Informed Consent Form and Patient Authorization for Release of Information approved by the appropriate Institutional Review Board (IRB) prior to screening and enrollment. If the subject is a minor (i.e., less than 18 years of age) both he and his parent or legal guardian must sign and date the informed consent.
- Diagnosis of severe hemophilia A.
- Levels of Factor VIII less than 0.01 IU/mL.
- Treatment with cryoprecipitate, Factor VIII concentrates, and/or whole blood, for at least 150 cumulative exposure days (CEDs) prior to enrollment.
- No treatment with cryoprecipitate, Factor VIII concentrate, or any other blood product, for at least 72 hours prior to screening.
- No previous diagnosis with inhibitors to Factor VIII at any detectable titer.
- Subjects must never have been diagnosed with nonspecific inhibitors of coagulation.
- Negative test for the presence of Factor VIII inhibitors at screening and enrollment.
- CD4 counts greater than or equal to 400 cells/µL.
- Vaccination against hepatitis A and hepatitis B, or evidence of antibodies against hepatitis A and hepatitis B. (A subject who has no prior immunity against hepatitis A will be offered a course of vaccination for hepatitis A).
- Karnofsky Performance Score of at least 50.
Exclusion
- Any immunosuppressive medications including intravenous immunoglobulins at the time of enrollment.
- Clinical signs or symptoms of an infection, such as fever, chills or nausea during screening or enrollment.
- History of frequent reactions to Factor VIII concentrates (e.g., chills or headaches).
- Prior treatment with Alphanate® (Solvent-Detergent/ Heat-Treated).
- Immunocompromised (including HIV+ status or has an impaired immune system due to disease or treatment).
Key Trial Info
Start Date :
April 8 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2018
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00323856
Start Date
April 8 2003
End Date
December 14 2018
Last Update
January 16 2025
Active Locations (2)
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1
Oddzial Chorob Wewnetrznych i Hematologii
Poznan, Szkolna, Poland
2
Katedra i Klinika Hematologii Collegium Medicum UJ
Krakow, Poland