Study Completed

Hemophilia A

Bayer Identifier:

15495

ClinicalTrials.gov Identifier:

NCT01653639

EudraCT Number:

2012-001045-40

EU CT Number:

Not Available

Comparative pharmacokinetic study of two different strengths of BAY14-2222

Trial purpose

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).

Key Participants Requirements

Sex

Male

Age

18 - 65 Years

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

Trial summary

Enrollment Goal

Trial Dates

July 2012 - December 2012

Phase

Phase 1

Could I Receive a placebo

Products

Kogenate FS (Recombinant Factor VIII, BAY14-2222)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD	Sofia, 1756, Bulgaria

Primary Outcome

Maximum plasma concentration (Cmax) of BAY14-2222
Time Frame:
Up to 48 hours
Safety Issue:
No
Area under the plasma concentration vs time curve from time 0 to time of last measurable concentration AUC(0-tlast) of BAY14-2222
Time Frame:
Up to 48 hours
Safety Issue:
No

Trial design

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)

Trial Type

Interventional

Intervention Type

Biological/Vaccine

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Crossover Assignment

Trial Arms

Additional Information

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