NCT00243659

Brief Summary

This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI).

Trial Health

93
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2006

Geographic Reach
7 countries

16 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

October 20, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 20, 2009

Completed
Last Updated

June 3, 2011

Status Verified

June 1, 2011

Enrollment Period

2.2 years

First QC Date

October 20, 2005

Results QC Date

May 29, 2009

Last Update Submit

June 2, 2011

Conditions

Hemophilia A

Keywords

Hemophilia Ableeding disorder

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Who Achieved Hemostatic Efficacy After Surgery

    Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.

    6 weeks

Secondary Outcomes (1)

  • Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge

    6 weeks

Study Arms (2)

A

EXPERIMENTAL
Biological: ReFacto AF

B

EXPERIMENTAL
Biological: ReFacto AF

Interventions

ReFacto AFBIOLOGICAL
AB

Eligibility Criteria

Age12 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor. * Previously treated with at least 150 exposure days to any Factor VIII product * Normal hepatic and renal function tests and no other bleeding disorder

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

La Jolla, California, 92093, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Detroit, Michigan, 48202, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27599, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, 15213, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Charlottesville, Virginia, 22908, United States

Location

Unknown Facility

Perth, Australia

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Auckland, New Zealand

Location

Unknown Facility

Chirstchurch, New Zealand

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Bucurest, Romania

Location

Unknown Facility

Malmo, Sweden

Location

Unknown Facility

Stockholm, Sweden

Location

MeSH Terms

Conditions

Hemophilia AHemostatic Disorders

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
U. S. Contact Center
Organization
Wyeth
clintrialresults@wyeth.com

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 24, 2005

Study Start

April 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 3, 2011

Results First Posted

July 20, 2009

Record last verified: 2011-06

Locations

HU(1)AU(1)NZ(2)RO(1)US(8)PL(1)SE(2)