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Study Evaluating ReFacto AF in Severe Hemophilia A

Last updated on December 15, 2017

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)

- Previously treated patients with greater than or equal to 250 exposure days to any
Factor VIII product

- Age greater than or equal to 12 years

- History of prophylaxis dosing at least twice per week on any Factor VIII product for
at least 3 consecutive months within the 2 years prior to study enrollment unless the
patient completed the previous pharmacokinetic study

- Adequate laboratory results

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

- Presence of any bleeding disorder in addition to hemophilia A

- Concomitant therapy with immunosuppressive drugs

- Current or historical Factor VIII inhibitor

- Treatment with any investigational drug or device within the past 30 days

NCT00037544
Pfizer
Completed
Study Evaluating ReFacto AF in Severe Hemophilia A

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Study Evaluating ReFacto AF in Severe Hemophilia A
An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A
To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.
Not Provided
Interventional
Phase 3
Primary Purpose: Treatment
Hemophilia A
Drug: ReFacto AF
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
Not Provided
August 2004
August 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe hemophilia A (FVIII:C less than or equal to 2% at local laboratory)
  • Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
  • Age greater than or equal to 12 years
  • History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
  • Adequate laboratory results

Exclusion Criteria:

  • Presence of any bleeding disorder in addition to hemophilia A
  • Concomitant therapy with immunosuppressive drugs
  • Current or historical Factor VIII inhibitor
  • Treatment with any investigational drug or device within the past 30 days
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00037544
3082B1-306
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
April 2008

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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1-800-718-1021

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