Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

Single Dose, Open-label, Randomized, Crossover Study in Subjects With Severe Hemophilia A to Compare the Bioavailability of 2 Different Strengths of Kogenate FS (BAY14-2222)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01653639

Enrollment

Registered

2012-07-31

Start date

2012-07-31

Completion date

2012-12-31

Last updated

2014-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

BAY14-2222, Pharmacokinetics

Brief summary

This is a single dose, open-label, randomized, crossover study in subjects with severe Hemophilia A to compare the bioavailability of 2 different strengths of Kogenate FS (BAY 14-2222).

Interventions

BIOLOGICALRecombinant Factor VIII (Kogenate FS, BAY14-2222)

50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Males, age 18 to 65 years * Subjects with Severe hemophilia A with a documented plasma FVIII level of \<1% * \>/= 150 ED (exposure days) with FVIII concentrates(s) as supported by medical records

Exclusion criteria

* Evidence of current or past inhibitor antibody * History of any congenital or acquired coagulation disorders other than hemophilia A * Platelet count \<75,000/mm3 * Abnormal renal function (serum creatinine \>2 times the upper limit of the normal range) * Active liver disease verified by medical history or persistently elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5x the upper limit of normal or severe 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

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentration (Cmax) of BAY14-2222	Up to 48 hours
Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222	Up to 48 hours

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026