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NCT00864552 Clinical Trial

International PMS Study - KOGENATE Bayer

Hemophilia A Clinical Trial

Official title:
International PMS Study - KOGENATE Bayer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00864552
Other study ID # 11145
Secondary ID 12252 - KG0201CH
Status Completed
Phase N/A
First received March 17, 2009
Last updated June 29, 2009
Start date December 2002
Est. completion date December 2005

Study information
Verified date June 2009
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with severe haemophilia A (<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII

Exclusion Criteria:

- Exclusion criteria must be read in conjunction with the product information (SmPC)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

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

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