International PMS Study - KOGENATE Bayer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Kogenate (BAY14-2222)

Drug

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2002
Study completion: 2005
First posted: Mar 18, 2009
Registry last updated: Jun 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed