Status:
COMPLETED
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia A
Eligibility:
All Genders
2-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water for injection ...
Eligibility Criteria
Inclusion
- The subject or subject's legally authorized representative has provided written informed consent
- The subject has severe hemophilia A as defined by a baseline FVIII activity \<= 1% of normal; tested at screening
- The adolescent/adult subject has a documented history of at least 150 exposure days to FVIII concentrates (either plasma-derived or recombinant), and the pediatric subject has at least 50 exposure days
- The subject is \>= 12 to \<= 65 years of age for the complete pharmacokinetic assessment and \>= 2 to \< 12 years for the incremental recovery assessment The subject has a Karnofsky performance score \> 60
- The subject is human immunodeficiency virus negative (HIV-) or HIV+ with stable CD4 count \>= 200 cells/mm³ (CD4 count determined at screening, if necessary)
Exclusion
- The subject has a known hypersensitivity to mouse or hamster proteins or to FVIII concentrates
- The subject has a history of FVIII inhibitors with titer \>= 0. 5 BU (Bethesda Assay) or \>= 0.4 BU (Nijmegen modification of the Bethesda Assay) any time prior to screening
- The subject has a detectable FVIII inhibitor at screening, \>= 0.4 BU (Nijmegen modification of the Bethesda Assay), in the central laboratory
- The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) \> 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices
- The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (e.g. qualitative platelet defect or Von Willebrand Disease)
- The subject has received another investigational product within 30 days of enrollment
- The subject's clinical condition may require major or moderate surgery (estimated blood loss \> 500 mL) during the period of participation in the study
- Subjects with clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance
- The subject is a female of childbearing potential with a positive pregnancy test at screening
Key Trial Info
Start Date :
August 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00952822
Start Date
August 8 2008
End Date
October 23 2009
Last Update
May 24 2021
Active Locations (11)
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1
Washington D.C., District of Columbia, United States
2
Atlanta, Georgia, United States
3
Lexington, Kentucky, United States
4
Louisville, Kentucky, United States