Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A

Brief Title

Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A

Official Title

Pharmacokinetic Comparison of 3000 IU Advate (rAHF-PFM) (Using One 3000 IU Potency Vial) With 3000 IU Advate (rAHF PFM) (Using Two 1500 IU Potency Vials) in Previously Treated Patients With Severe Hemophilia A: a Phase 4, Open-label, Prospective, Randomized, Controlled, Crossover, Multiple Center Study

Brief Summary

      The objective of this clinical study is to compare the pharmacokinetic parameters of 3000 IU
      Advate using one 3000 IU potency vial dissolved in 5 mL diluent with that of 3000 IU Advate
      using two vials of 1500 IU potency dissolved in 5 mL diluent each (administered in 10 mL
      diluent in total) in previously treated patients with severe hemophilia A (factor VIII level
      < 1%).

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay

Secondary Outcome

 Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay

Condition

Hemophilia A

Intervention

Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]

Study Arms / Comparison Groups

Description:  One infusion using a 3000 IU potency vial of Advate dissolved and administered in 5 mL diluent followed by a second infusion of two 1500 IU potency vials of Advate dissolved in 5 mL diluent each (administered in 10 mL diluent in total)

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

Start Date

June 29, 2009

Completion Date

April 1, 2010

Primary Completion Date

April 1, 2010

Eligibility Criteria

        Inclusion Criteria:

          -  Participant is 18 to 65 years old, at the time of screening

          -  Participant has provided signed informed consent

          -  Participant has severe hemophilia A, defined by a baseline FVIII level < 1% of normal,
             as tested at screening at the central laboratory

          -  Participant's weight is between 55-65 kg

          -  Participant was previously treated with FVIII concentrate(s) for a minimum of 150
             exposure days prior to study entry

          -  If Participant is HIV positive, he must be immunocompetent as determined with a CD4
             count ≥ 200 cells/mm³ (CD4 count at screening)

          -  Participant is willing and able to comply with the requirements of the protocol

        Exclusion Criteria:

          -  Participant has a detectable FVIII inhibitor at screening, with a titer ≥ 0.4 Bethesda
             unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the central
             laboratory

          -  Participant has a history of FVIII inhibitors with a titer ≥ 0.4 BU (by Nijmegen
             assay) or ≥ 0.5 BU (by Bethesda Assay) at any time prior to screening

          -  Participant has undergone a surgery within 21 days prior to screening or within 6
             weeks prior to the anticipated first pharmacokinetics(PK) infusion

          -  Participant has an abnormal renal function (serum creatinine > 1.5 mg/dL)

          -  Participant has active hepatic disease (alanine aminotransferase (ALT) or aspartate
             aminotransferase (AST) levels >5 times the upper limit of normal)

          -  Participant 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

          -  Participant has clinical and/or laboratory evidence of abnormal hemostasis from causes
             other than hemophilia A (eg, late-stage chronic liver disease, immune thrombocytopenia
             purpura)

          -  Participant is currently receiving, or is scheduled to receive during the course of
             the clinical study, an immunomodulating drug other than anti-retroviral chemotherapy
             (eg, alfa-interferon, or corticosteroid agents at a dose equivalent to hydrocortisone
             greater than 10 mg/day)

          -  Participant has a known hypersensitivity to mouse or hamster proteins

          -  Participant has participated in another clinical study involving an investigational
             product or investigational device within 30 days prior to enrollment or is scheduled
             to participate in another clinical study involving an investigational product or
             investigational device during the course of this clinical study

          -  Participant is identified by the investigator as being unable or unwilling to
             cooperate with study procedures

          -  Participant is a member of the team conducting this clinical study or is in a
             dependent relationship with one of the study team members. Dependent relationships
             include close relatives (ie, children, partner/spouse, siblings, or parents) as well
             as employees of the investigator or site personnel conducting the clinical study.

Gender

Male

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Study Director, ,

Location Countries

Bulgaria

Location Countries

Bulgaria

Administrative Informations

NCT ID

NCT00916032

Organization ID

Secondary IDs

2008-007347-13

Responsible Party

Sponsor

Study Sponsor

Baxalta now part of Shire

Study Sponsor

Study Director, Study Director, Takeda

Verification Date

April 2021