Kogenate FS Regulatory Post-Marketing Surveillance

NCT01386268 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2014-08-21

No results posted yet for this study

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

Interventions

BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-01-31
Completion
2013-08-31

Countries

  • South Korea

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01386268 on ClinicalTrials.gov