Comparative Pharmacokinetic Study of Two Different Streng... | NCT01653639

Studies
Comparative Pharmacokinetic Study of Two Different Strengths of BAY14-2222

NCT01653639

Sponsor

Bayer

Status

Completed

Last Update Posted

Jan 10, 2014Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Hemophilia A

Interventions

Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Countries

Bulgaria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-001045-40	EudraCT Number

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Jul 27, 2012

First Submission Date that Met QC Criteria

Jul 27, 2012

First Posted Date

Jul 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2014

Last Update Posted Date

Jan 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Arm 2	Experimental		Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recombinant Factor VIII (Kogenate FS, BAY14-2222)	Biological	50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005169	Factor VIII
C078147	F8 protein, human
C414350	BAY 14-2222

Ancestor Terms

ID	Term
D001779	Blood Coagulation Factors
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided