Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980

Brief Title

Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980

Official Title

A Randomized, Double-blind, Cross-over Study to Determine the Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980 in Previously Treated Patients With Severe Hemophilia A

Brief Summary

      The primary objective of this study is to determine the pharmacokinetic profile after single
      administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22
      mg and 13 mg of liposomes/Kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in
      2.5 mL WFI/1000 IU) in PTPs aged 12 to 60 years with severe hemophilia A.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

To determine the pk profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg and 13 mg of liposomes/kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in 2.5 mL WFI/1000 IU) in PTPs

Secondary Outcome

 To determine the infusion tolerability of both BAY 79-4980 doses, by evaluation of vital signs and adverse events

Condition

Hemophilia A

Intervention

Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)

Study Arms / Comparison Groups

 Arm 1

Description:

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

September 2005

Completion Date

March 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Males aged 12 to 60 years

          -  Hemophilia A with plasma FVIII level less than 1% (severe hemophilia)

          -  No history of FVIII inhibitor antibody formation and no current evidence of inhibitor
             antibody measured using the Nijmegen modified Bethesda assay (< 0.6 Nijmegen Bethesda
             Units [N.B.U.]/mL)

          -  No signs or symptoms of an acute bleeding episode on the day of infusion

          -  Four or more days without treatment with FVIII prior to the day of infusion

          -  Subject (or the subject's legal representative) must provide written informed consent
             and authorization of use and disclosure of Protected Health Information (PHI)

          -  Subjects must have been previously treated with FVIII concentrate for a total of at
             least 200 exposure days, including 20 exposure days in the previous 12 months.
             Previous treatment can have been with any type of rFVIII or plasma-derived FVIII
             concentrate

        Exclusion Criteria:

          -  Individuals with abnormal renal function (serum creatinine concentrations greater than
             1.3 mg/dL) or active hepatic disease (persistent aspartate aminotransferase [AST] or
             alanine aminotransferase [ALT] increases to greater than five times the upper limit of
             normal).

          -  Individuals with anemia, as defined by hemoglobin level less than 12 g/dL

          -  Any individual with a past history of severe reaction(s) to FVIII products

          -  Any individual on interferon treatment or who has received interferon within the
             previous 3 months

          -  Any individual with thrombocytopenia (platelets greater than or equal to 100,000
             cells/mm3) or known hematologic/bleeding problems other than hemophilia A

          -  Any individual who is receiving or has received other experimental drugs within 3
             months prior to study entry

          -  Any individual with known dislipidemic disease or actively taking cholesterol lowering
             drugs for the treatment of hypercholesterolemia or hyperlipidemia (e.g., statins,
             cholesterol absorption inhibitors, bile acid sequestrants, nicotinic acid or fibrates)
             or individuals taking anaesthetic drugs

          -  Any individual who requires pre-medication for FVIII infusions (e.g., antihistamines)

          -  Any individual with high blood pressure (defined as diastolic blood pressure great
             than or equal to 100 mm/Hg)

          -  Any patient who cannot forego FVIII treatment for at least 4 days prior to study entry
             or between study infusions due to a need for more frequent prophylactic treatment
             because of a pre-existing medical condition

          -  Any patient with known allergy or severe reactions to liposomes or PEG

          -  Individuals with any other known disease affecting hemostasis besides hemophilia A

          -  Any patient who is not suitable for participation in this trial for any reason,
             according to the Investigator

Gender

Male

Ages

12 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Bayer Study Director, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00629837

Organization ID

Secondary IDs

LipLong

Responsible Party

Sponsor

Study Sponsor

Bayer

Study Sponsor

Bayer Study Director, Study Director, Bayer

Verification Date

November 2014