NCT00092976

Brief Summary

The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2004

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

December 28, 2007

Status Verified

May 1, 2006

First QC Date

September 28, 2004

Last Update Submit

December 19, 2007

Conditions

Hemophilia A

Keywords

Hemophilia A

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and efficacy of ReFacto in subjects with Hemophilia A undergoing major surgery monitored using the chromogenic substrate assay at the local laboratory.

Secondary Outcomes (1)

  • To compare FVIII:C levels determined using the one-stage and the chromogenic substrate assays at a central laboratory

Interventions

ReFactoDRUG

Eligibility Criteria

Age6 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 6 years
  • Male previously treated patients (≥150 Exposure Days) with moderate or severe hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis)
  • Ability to adhere to the protocol requirements

You may not qualify if:

  • Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as \> 0.6 BU
  • Prior participation in this study
  • Any concomitant bleeding disorder other than hemophilia A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Los Angeles, California, 90007, United States

Location

Unknown Facility

New Brunswick, New Jersey, 08903-0019, United States

Location

Unknown Facility

Cincinnati, Ohio, 45229, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

recombinant factor VIII SQ

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

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2004

First Posted

September 29, 2004

Study Start

February 1, 2003

Study Completion

July 1, 2007

Last Updated

December 28, 2007

Record last verified: 2006-05

Locations

US(4)