NCT00874926

Brief Summary

The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
17 countries

17 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

June 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

4.4 years

First QC Date

April 2, 2009

Last Update Submit

January 28, 2014

Conditions

Hemophilia A

Keywords

Octocog alfaHaemophilia A

Outcome Measures

Primary Outcomes (1)

  • Efficacy and Safety of Kogenate Bayer/FS

    After 12 months, after 24 months

Study Arms (1)

Group 1

Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Interventions

Recombinant Factor VIII (Kogenate FS, BAY14-2222)BIOLOGICAL

Haemophilia A patients

Group 1

Eligibility Criteria

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

Haemophilia A patients, no specific study population

You may qualify if:

  • Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Many Locations, Bahrain

Location

Unknown Facility

Many Locations, Bosnia and Herzegovina

Location

Unknown Facility

Many Locations, Croatia

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Israel

Location

Unknown Facility

Many Locations, Kazakhstan

Location

Unknown Facility

Many Locations, Kuwait

Location

Unknown Facility

Many Locations, Libya

Location

Unknown Facility

Many Locations, Morocco

Location

Unknown Facility

Many Locations, Oman

Location

Unknown Facility

Many Locations, Qatar

Location

Unknown Facility

Many Locations, Romania

Location

Unknown Facility

Many Locations, Russia

Location

Unknown Facility

Many Locations, Saudi Arabia

Location

Unknown Facility

Many Locations, Slovenia

Location

Unknown Facility

Many Locations, Tunisia

Location

Unknown Facility

Many Locations, United Arab Emirates

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIIIF8 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

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2009

First Posted

April 3, 2009

Study Start

June 1, 2008

Primary Completion

November 1, 2012

Study Completion

April 1, 2013

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

BO(1)CR(1)DE(1)KU(1)BA(1)QA(1)SL(1)RO(1)TU(1)RU(1)SA(1)AE(1)LI(1)IL(1)MO(1)OM(1)KA(1)