Kogenate FS Regulatory Post-Marketing Surveillance | NCT01386268

Studies
Kogenate FS Regulatory Post-Marketing Surveillance

NCT01386268

Sponsor

Bayer

Status

Completed

Last Update Posted

Aug 21, 2014Estimated

Enrollment

64Actual

Phase

Not provided

Conditions

Hemophilia A

Interventions

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Countries

South Korea

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
KG0910KR	Other Identifier	Company Internal

Status Module

Record Verification Date

Aug 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

Jun 2011

Primary Completion Date

Jan 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Jun 14, 2011

First Submission Date that Met QC Criteria

Jun 30, 2011

First Posted Date

Jul 1, 2011Estimated

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

Aug 20, 2014

Last Update Posted Date

Aug 21, 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

To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.

The observation period for each patient is up to 6 months.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			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	Patients with diagnosis of hemophilia A, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety variables will be summarized using descriptive statistics based on adverse events collection		Up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Type of the treatment (prophylaxis, on demand, surgery)		Initial visit and 6 month f/u or at the end of the observation visit
Total consumption of FVIII		Initial visit and 6 month f/u or at the end of the observation visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with diagnosis of hemophilia A
Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
Signed the informed consent form to participate in this study.
For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available
For pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available
For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA
Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician.

Exclusion Criteria:

Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with hemophilia A in Korea

Sampling Method

Non-Probability Sample

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