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Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings

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NCT00884390

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Wien, , 1090 Austria
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male patients greater than or equal to 12 years of age with severe hemophilia A
(FVIII:C less than 1%).

- Treatment history of greater than 150 EDs to prior recombinant or plasma-derived FVIII
replacement products.

- Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII
replacement products.

- Serum albumin greater than or equal to the lower limit of normal (LLN).

- Platelet count greater than or equal to 100,000/µL.

- Prothrombin time (PT) less than or equal to1.25 × ULN, or international normalized
ratio (INR) less than or equal to 1.5.

- HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load
less than 200 particles/µL.

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.

- A positive FVIII inhibitor, according to the local laboratory, at screening; or any
Bethesda Inhibitor Titer greater than 0.6, regardless of the normal range for the
testing laboratory.

- Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI])
during the screening period.

- Prior exposure to moroctocog alfa (AF-CC).

- Known hypersensitivity to hamster protein.

NCT00884390
Pfizer
Terminated
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings

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Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
A Postauthorization Safety Surveillance Study Of Patients Switching To ReFacto AF From ReFacto Or Other Factor VIII Products In Usual Care Settings
The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.
The trial was terminated prematurely on 28 March 2013, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns and agreement to close the study in March 2013 was agreed with EMA prior to closure activity.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemophilia A
  • Drug: moroctocog alfa (AF-CC) (ReFacto AF)
    Providing moroctocog alfa (AF-CC) as test article for use during this study.
  • Procedure: Laboratory tests
    Laboratory samples are collected during study visits, in order to collect safety and efficacy data related to the administration of test article.
Experimental: ReFacto AF
Interventions:
  • Drug: moroctocog alfa (AF-CC) (ReFacto AF)
  • Procedure: Laboratory tests
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
208
March 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male patients greater than or equal to 12 years of age with severe hemophilia A (FVIII:C less than 1%).
  • Treatment history of greater than 150 EDs to prior recombinant or plasma-derived FVIII replacement products.
  • Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products.
  • Serum albumin greater than or equal to the lower limit of normal (LLN).
  • Platelet count greater than or equal to 100,000/µL.
  • Prothrombin time (PT) less than or equal to1.25 × ULN, or international normalized ratio (INR) less than or equal to 1.5.
  • HIV positive subjects must have a CD4 count greater than 200/µL and HIV viral load less than 200 particles/µL.

Exclusion Criteria:

  • Presence of any bleeding disorder in addition to hemophilia A.
  • A positive FVIII inhibitor, according to the local laboratory, at screening; or any Bethesda Inhibitor Titer greater than 0.6, regardless of the normal range for the testing laboratory.
  • Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI]) during the screening period.
  • Prior exposure to moroctocog alfa (AF-CC).
  • Known hypersensitivity to hamster protein.
Sexes Eligible for Study: Male
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Romania,   Spain,   Sweden,   United Kingdom
 
 
NCT00884390
3082B2-4432
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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