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International PMS Study - KOGENATE Bayer

NCT00864552 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2009-06-30

No results posted yet for this study

Summary

To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand.

To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.

Conditions

Interventions

DRUG

Kogenate (BAY14-2222)

Patients with severe haemophilia A (\<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Completion
2005-12-31

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Greece
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland

More Related Trials

Entities

Diseases
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 NCT00864552 on ClinicalTrials.gov