NCT00922597

Brief Summary

The objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Geographic Reach
7 countries

7 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

August 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

April 20, 2015

Status Verified

April 1, 2015

First QC Date

June 16, 2009

Last Update Submit

April 17, 2015

Conditions

Hemophilia A

Keywords

Continuous infusionSurgerySevere haemophilia A

Outcome Measures

Primary Outcomes (1)

  • Total consumption of FVIII (in IU/kg) during continuous infusion, FVIII:C achieved compared to expected levels, reasons and number of unplanned bolus infusion, amount of blood loss, transfusion requirements

    During continuous infusion

Secondary Outcomes (1)

  • General tolerability and development of inhibitors

    Within 14 days to 3 months after termination of continuous infusion

Study Arms (1)

Group 1

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

Interventions

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

Patients undergoing surgery and receiving continuous infusion with Kogenate Bayer 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 severe haemophilia A. Physicians should consult the full prescribing information for KOGENATE Bayer before enrolling patients and familiarize themselves with the safety information in the product information.

You may qualify if:

  • In-patients with diagnosis of severe haemophilia A (FVIII \< 1%), heavily pretreated (\> 150 exposure days), without any history of inhibitors, a negative inhibitor test should be available, decision taken by the investigator to administer KOGENATE Bayer via continuous infusion during and after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Many Locations, Austria

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Greece

Location

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Netherlands

Location

Unknown Facility

Many Locations, Slovenia

Location

Unknown Facility

Many Locations, Spain

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

June 16, 2009

First Posted

June 17, 2009

Study Start

August 1, 2008

Study Completion

September 1, 2011

Last Updated

April 20, 2015

Record last verified: 2015-04

Locations

DE(1)AU(1)GR(1)IT(1)NL(1)SL(1)ES(1)