Kogenate FS Regulatory Post-Marketing Surveillance

NCT01386268 | Completed

• 2 other identifiers: 14927KG0910KR
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A

Keywords

Kogenate FS; Hemophilia A

Outcome Measures

Primary Outcomes (1)

• Safety variables will be summarized using descriptive statistics based on adverse events collection

  Up to 6 months

Secondary Outcomes (4)

• 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

• Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively)

  Initial visit, 6 month follow-up visit and 12 month follow-up visit

• General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient

  6 month f/u or at the end of observation visit

Study Arms (1)

Group 1

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

Interventions

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

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hemophilia A in Korea

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, South Korea

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII; F8 protein, human; BAY 14-2222

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: July 1, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

KR (1)