Brief Title
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection
Official Title
A Phase 1, Prospective, Randomized, Crossover Study to Compare the Pharmacokinetics and Safety of rAHF-PFM Reconstituted in 2 mL Versus 5 mL SWFI in Previously Treated Severe Hemophilia A Patients
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 (SWFI) and compare with those of rAHF-PFM reconstituted in 5 mL of SWFI.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Area Under the Curve
Secondary Outcome
Total Area Under the Curve
Condition
Hemophilia A
Intervention
Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII)
Study Arms / Comparison Groups
1
Description: ADVATE reconstituted in 2 mL sterile water for infusion
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
52
Start Date
August 8, 2008
Completion Date
October 23, 2009
Primary Completion Date
October 23, 2009
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
All
Ages
2 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Study Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00952822
Organization ID
060702
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Study Sponsor
Study Director, Study Director, Takeda
Verification Date
April 2021