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Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Los Angeles, California, 90007 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00092976
Pfizer
Completed
Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery

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Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
A Phase IV Study of the Safety and Efficacy of ReFacto® (Moroctocog Alfa, B-Domain Deleted Recombinant Factor VIII) in Subjects With Hemophilia A Undergoing Major Surgery Monitored Using the Chromogenic Substrate Assay at the Local Laboratory
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemophilia A
Drug: ReFacto
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
July 2007
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: Male
6 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00092976
3082A2-401
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
May 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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