Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Bayer |
---|---|
Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00629837 |
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.
Condition | Intervention | Phase |
---|---|---|
Hemophilia A |
Biological: Kogenate (BAY 79-4980) Biological: rFVIII-FS |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Pharmacokinetics Study |
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 |
Enrollment: | 27 |
Study Start Date: | September 2005 |
Study Completion Date: | March 2006 |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Biological: Kogenate (BAY 79-4980)
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).
|
Arm 2: Experimental |
Biological: Kogenate (BAY 79-4980)
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)
|
Arm 3: Active Comparator |
Biological: rFVIII-FS
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: Active Comparator |
Biological: rFVIII-FS
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]
|
Ages Eligible for Study: | 12 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bayer Schering Pharma AG ( Therapeutic Area Head ) |
Study ID Numbers: | 11876, LipLong |
Study First Received: | February 27, 2008 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00629837 History of Changes |
Health Authority: | United States: Food and Drug Administration |
FVIII Long acting pk |
Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases Blood Coagulation Disorders |
Hemophilia A Hemostatic Disorders Factor VIII |
Hemorrhagic Disorders Blood Coagulation Disorders, Inherited Coagulants Genetic Diseases, Inborn Coagulation Protein Disorders Hematologic Diseases |
Therapeutic Uses Blood Coagulation Disorders Hematologic Agents Hemophilia A Pharmacologic Actions Factor VIII |