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Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients

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NCT00914459

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Kuopio University Hospital
Kuopio, , 70211 Finland
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
0-11
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male subjects less than 12 years of age with a documented history of severe hemophilia
A (FVIII:C less than 1%).

- Subjects who are less than 6 years of age must have had at least 50 Exposure Days
(EDs) to prior FVIII products (including blood products).

- Subjects who are equal to or greater than 6 years of age must have had greater than
150 EDs to prior FVIII products (including blood products).

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

- For laboratory assessments, any measured Bethesda inhibitor titer equal to or greater
than 0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor
titer greater than ULN for the testing laboratory at the time of screening.

- Any other bleeding disorder in addition to hemophilia A.

- Treatment with any investigational drug or device within 30 days before the time of
signing the parental informed consent/assent form.

- Major surgery planned to occur during the course of the study.

- Regular (e.g., daily; every other day) use of agents or medications known to influence
platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs
(NSAIDS).

- Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous
immunoglobulin [IVIG], routine systemic corticosteroids), or currently receiving
immune tolerance induction (ITI) for inhibitor treatment.

- The subject is receiving treatment for HIV or hepatitis infection (unless the subject
is on a stable antiviral regimen [i.e., consistent treatment regimen for at least 3
months before the parental informed consent/assent form is signed]).

- Platelet count less than 100,000/µL.

- Prothrombin time (PT) equal to or greater than 1.25 x ULN, or international normalized
ratio (INR) equal to or greater than 1.5.

- Known hypersensitivity to hamster protein.

NCT00914459
Pfizer
Completed
Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients

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Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
A Non-randomized, Open-label Study To Evaluate The Pharmacokinetics, Safety And Efficacy Of Refacto Af In Previously Treated Pediatric Subjects Less Than Twelve Years Of Age With Severe Hemophilia A (Fviii:c <1%).
The study will be investigating pharmacokinetics, safety and efficacy in patients less than 12 years of age with severe hemophilia A that have been previously treated with Factor VIII products ( including blood products).
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemophilia A
  • Biological: Moroctocog alfa ( AF-CC)
    Dosing is at the discretion of the Investigator
    Other Name: ReFacto AF
  • Procedure: Laboratory tests
    Factor VIII PK samples, Hematology, Chemistry and Coagulation testing, FactorVIII Inhibitor and Anti Factor VIII antibody
Moroctocog alfa (AF-CC)
Open Label
Interventions:
  • Biological: Moroctocog alfa ( AF-CC)
  • 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.
 
Completed
37
April 2016
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male subjects less than 12 years of age with a documented history of severe hemophilia A (FVIII:C less than 1%).
  • Subjects who are less than 6 years of age must have had at least 50 Exposure Days (EDs) to prior FVIII products (including blood products).
  • Subjects who are equal to or greater than 6 years of age must have had greater than 150 EDs to prior FVIII products (including blood products).

Exclusion Criteria:

  • For laboratory assessments, any measured Bethesda inhibitor titer equal to or greater than 0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor titer greater than ULN for the testing laboratory at the time of screening.
  • Any other bleeding disorder in addition to hemophilia A.
  • Treatment with any investigational drug or device within 30 days before the time of signing the parental informed consent/assent form.
  • Major surgery planned to occur during the course of the study.
  • Regular (e.g., daily; every other day) use of agents or medications known to influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs (NSAIDS).
  • Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous immunoglobulin [IVIG], routine systemic corticosteroids), or currently receiving immune tolerance induction (ITI) for inhibitor treatment.
  • The subject is receiving treatment for HIV or hepatitis infection (unless the subject is on a stable antiviral regimen [i.e., consistent treatment regimen for at least 3 months before the parental informed consent/assent form is signed]).
  • Platelet count less than 100,000/µL.
  • Prothrombin time (PT) equal to or greater than 1.25 x ULN, or international normalized ratio (INR) equal to or greater than 1.5.
  • Known hypersensitivity to hamster protein.
Sexes Eligible for Study: Male
up to 11 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Georgia,   Italy,   Romania,   Serbia,   Spain,   Sweden,   Turkey,   Ukraine
Bulgaria,   Greece,   Poland
 
NCT00914459
3082B2-4433
B1831005 ( Other Identifier: Alias Study Number )
2008-008435-29 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2016

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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1-800-718-1021

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