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

Completed · Phase 3

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT00543439

Run by

Pfizer

People needed

66

Starts

2007-12-01

Expected to finish

2018-04-01

Last updated by the study team

2019-01-11

Who can join

Age: 1 and older, up to 15. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• OHSU Investigational Pharmacy — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Childrens Medical Center Dallas — Dallas, Texas, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Fundacion de la Hemofilia — Buenos Aires, Argentina
• Medizinische Universitaet Wien — Vienna, Austria
• Liga Colombiana de Hemofílicos y otras Deficiencias Sanguíneas — Bogotá, Colombia
• Clinical Hospital Centre Split — Split, Croatia
• Jordan University of Science and Technology, King Abdullah University Hospital — Irbid, Jordan
• Hospital Civil de Guadalajara Dr. Juan I. Menchaca — Guadalajara, Jalisco, Mexico
• Hospital y Clinica OCA S.A. de C.V. — Colonia Centro, Monterrey, Nuevo LEON, Mexico
• Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey, Nuevo León, Mexico
• Christchurch Hospital — Christchurch, South Island, New Zealand
• Canterbury District Health Board — Christchurch, New Zealand
• Sultan Qaboos University Hospital — Muscat, Oman
• Centro Medico Monte Carmelo — Urbanización La Victoria, Arequipa, Peru
• Samodzielny Publiczny Dzieciecy Szpital Kliniczny — Warsaw, Poland
• Sanador — Bucharest, Romania
• Cukurova University Tip Fakultesi — Balcali/Adana, Adana, Turkey (Türkiye)
• Ege Universitesi Tip Fakultesi Cocuk Hastanesi — Izmir, Bornova, Turkey (Türkiye)
• Istanbul Universtesi Istanbul Tip Fakultesi — Çapa, Istanbul, Turkey (Türkiye)
• On Dokuz Mayis University Faculty of Medicine — Samsun, Kurupelit, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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