NCT00864552

Brief 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2002

Typical duration for all trials

Geographic Reach
10 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

First QC Date

March 17, 2009

Last Update Submit

June 29, 2009

Conditions

Hemophilia A

Keywords

Hemophilia ARecombinant Factor VIII

Study Arms (1)

Group 1

Drug: Kogenate (BAY14-2222)

Interventions

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

Group 1

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Many Locations, Austria

Location

Unknown Facility

Many Locations, Belgium

Location

Unknown Facility

Many Locations, Denmark

Location

Unknown Facility

Many Locations, France

Location

Unknown Facility

Many Locations, Greece

Location

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Netherlands

Location

Unknown Facility

Many Locations, Spain

Location

Unknown Facility

Many Locations, Sweden

Location

Unknown Facility

Many Locations, Switzerland

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

F8 protein, humanBAY 14-2222

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

December 1, 2002

Study Completion

December 1, 2005

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

AU(1)IT(1)ES(1)DK(1)NL(1)BE(1)SE(1)FR(1)GR(1)CH(1)