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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Kuopio University Hospital
Kuopio, , 70211 Finland
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
0-11
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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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Pfizer Clinical Trials Contact Center

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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