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

NCT ID: NCT00629837

Last Updated: 2014-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-03-31

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.

Conditions

Hemophilia A

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Low dose of BAY 79-4980 \[13mg of liposomes/kg\] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU).

Arm 2

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

High dose of BAY 79-4980 \[22mg of liposomes/kg\] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU)

Arm 3

Group Type: ACTIVE_COMPARATOR

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type: BIOLOGICAL

rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to low dose of BAY 79-4980 \[13mg of liposomes/kg\]

Arm 4

Group Type: ACTIVE_COMPARATOR

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type: BIOLOGICAL

rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to high dose of BAY 79-4980 \[22mg of liposomes/kg\]

Interventions

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

Low dose of BAY 79-4980 \[13mg of liposomes/kg\] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU).

Intervention Type: BIOLOGICAL

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

High dose of BAY 79-4980 \[22mg of liposomes/kg\] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU)

Intervention Type: BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to low dose of BAY 79-4980 \[13mg of liposomes/kg\]

Intervention Type: BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to high dose of BAY 79-4980 \[22mg of liposomes/kg\]

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Davis, California, United States

Orange, California, United States

Countries

United States

Other Identifiers

LipLong

Identifier Type: -

Identifier Source: secondary_id

11876

Identifier Type: -

Identifier Source: org_study_id