Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII



Status:Completed
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any - 15
Updated:1/13/2019
Start Date:December 2007
End Date:April 2018

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An Open-label Study To Evaluate Prophylaxis Treatment, And To Characterize The Efficacy, Safety, And Pharmacokinetics Of B-domain Deleted Recombinant Factor Viii Albumin Free (Moroctocog Alfa [Af-cc]) In Children With Hemophilia A

The purpose of this research study is to determine the effectiveness, safety, and
pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are
younger than 6 years of age, with severe or moderately severe hemophilia A.


Inclusion Criteria:

- Male subjects, aged less than 6 years, with moderately severe to severe hemophilia A.

- A negative FVIII inhibitor titer at screening, and a medical history negative for a
past FVIII inhibitor.

- At least 20 exposure days to any FVIII replacement product.

- Adequate hepatic and renal function

- CD4 count > 400 cells/uL, and if receiving antiviral therapy must be on a stable
regimen

Additional criteria for subjects participating in the PK assessment:

- Male subjects as described immediately above except they must have a FVIII Activity of
less than or equal to 1% confirmed by the central laboratory screening test

- Age < 6 years at time of PK assessment.

- The subject's size is sufficient to permit PK-related phlebotomy.

- The subject is able to comply with the procedures conducted during the PK assessment,
including a mandatory 72-hour washout period preceding the PK assessment.

Exclusion Criteria:

- A history of FVIII inhibitor.

- Presence of a bleeding disorder in addition to hemophilia A.

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

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

- Regular (e.g., daily, every other day) use of antifibrinolytic agents or medications
known to influence platelet function such as aspirin or certain nonsteroidal
anti-inflammatory drugs (NSAIDs), or regular, concomitant therapy with
immunomodulating drugs (e.g., intravenous immunoglobulin [IVIG], routine systemic
corticosteroids).

- Known hypersensitivity to hamster protein.
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Portland, Oregon 97239
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Salt Lake City, Utah 84143
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