NCT00969319

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
2 countries

2 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

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

3.4 years

First QC Date

August 31, 2009

Last Update Submit

January 16, 2015

Conditions

Blood Coagulation DisordersHemophilia A

Keywords

Octocog alfaHemophilia A

Outcome Measures

Primary Outcomes (5)

  • Total consumption of FVIII

    After 12 months and after 24 months

  • Number of bleedings

    After 12 months and after 24 months

  • Kind of bleedings

    After 12 months and after 24 months

  • Continuation of therapy

    After 12 months and after 24 months

  • Overall assessment by the physician

    After 12 months and after 24 months

Secondary Outcomes (1)

  • Adverse event collection

    After 12 months and 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

Patients under daily life treatment receiving Kogenate according to local drug information.

Group 1

Eligibility Criteria

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

The study population will consist of patients with a diagnosis of hemophilia A. Physicians should consult the full prescribing information for KOGENATE® FS before enrolling patients and familiarize themselves with the safety information in the product package label.

You may qualify if:

  • Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE® 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 (2)

Unknown Facility

Many Locations, Mexico

Location

Unknown Facility

Many Locations, Venezuela

Location

MeSH Terms

Conditions

Blood Coagulation DisordersHemophilia A

Interventions

Factor VIIIF8 protein, humanBAY 14-2222

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesBlood Coagulation Disorders, InheritedCoagulation 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

August 31, 2009

First Posted

September 1, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2014

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

VE(1)ME(1)