Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

Hemophilia A Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653639
• Other study ID #: 15495
• Secondary ID: 2012-001045-40
• Status: Completed
• Phase: Phase 1
• First received: July 27, 2012
• Last updated: January 8, 2014
• Start date: July 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Biological:
• Recombinant Factor VIII (Kogenate FS, BAY14-2222)
50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)
• Recombinant Factor VIII (Kogenate FS, BAY14-2222)
50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of BAY14-2222		Up to 48 hours	No
Primary	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	No

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