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

NCT00884390

Last updated date
Study Location
Pfizer Investigational Site
Wien, , 1090, Austria
Contact
1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
Official Title  ICMJE A Postauthorization Safety Surveillance Study Of Patients Switching To ReFacto AF From ReFacto Or Other Factor VIII Products In Usual Care Settings
Brief Summary The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemophilia A
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: ReFacto AF
Interventions:
  • Drug: moroctocog alfa (AF-CC) (ReFacto AF)
  • Procedure: Laboratory tests
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 20, 2014)
208
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2009)
300
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Netherlands,   Romania,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00884390
Other Study ID Numbers  ICMJE 3082B2-4432
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP