Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: Moroctocog alfa (AF-CC) (Biological); Moroctocog alfa (AF-CC) (Biological)
Phase: Phase 3
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
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.
Clinical Details
Official title: An Open-Label Study To Evaluate Prophylaxis Treatment, And To Characterize The Efficacy, Safety, And Pharmacokinetics (PK) Of B Domain Deleted Recombinant Factor VIII Albumin Free (Moroctocog Alfa [AF-CC]) In Children With Hemophilia A
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The annualized bleed rate is the primary endpoint for testing the primary objective of the study (comparing prophylaxis to on-demand therapy)
Secondary outcome: The annualized bleed rate is the endpoint for testing one of the secondary objectives (comparing high vs low frequency prophylaxis regimens).Number of moroctocog alfa (AF-CC) infusions per bleed Response of bleed to moroctocog alfa (AF-CC) treatment (4-point scale of assessment) Time interval between bleed onset and prior moroctocog alfa (AF-CC) prophylaxis dose Incidence of prophylaxis regimen escalation Incidence of Less than Expected Therapeutic Effect Consumption of moroctocog alfa (AF-CC) Compliance with assigned prophylaxis regimen Incidence of Adverse Events Incidence of confirmed FVIII inhibitor development
Eligibility
Minimum age: N/A.
Maximum age: 6 Years.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Buenos Aires C1425BWE, Argentina; Completed
Pfizer Investigational Site, Wien 1090, Austria; Completed
Pfizer Investigational Site, Split 21000, Croatia; Recruiting
Pfizer Investigational Site, Beirut 2833-7401, Lebanon; Not yet recruiting
Pfizer Investigational Site, Christchurch, New Zealand; Recruiting
Pfizer Investigational Site, Arequipa, Peru; Recruiting
Pfizer Investigational Site, Warszawa 00-576, Poland; Active, not recruiting
Pfizer Investigational Site, Bucuresti 011155, Romania; Recruiting
Pfizer Investigational Site, Antalya 07059, Turkey; Recruiting
Pfizer Investigational Site, Balcali/Adana 01330, Turkey; Recruiting
Pfizer Investigational Site, Bornova/Izmir 35100, Turkey; Recruiting
Pfizer Investigational Site, Capa/Istanbul 34390, Turkey; Recruiting
Pfizer Investigational Site, Fatih/Istanbul 34098, Turkey; Recruiting
Pfizer Investigational Site, Kayseri 38039, Turkey; Recruiting
Pfizer Investigational Site, Bogota, Cundinamarca 0000, Colombia; Recruiting
Pfizer Investigational Site, Washington, District of Columbia 20010, United States; Not yet recruiting
Pfizer Investigational Site, Guadalajara, Jalisco 44340, Mexico; Recruiting
Pfizer Investigational Site, Monterrey, Nuevo Leon 64460, Mexico; Recruiting
Pfizer Investigational Site, Monterrey, Nuevo Leon 64000, Mexico; Recruiting
Pfizer Investigational Site, Cincinnati, Ohio 45229-3039, United States; Completed
Pfizer Investigational Site, Portland, Oregon 97239, United States; Completed
Pfizer Investigational Site, Dallas, Texas 75390, United States; Completed
Pfizer Investigational Site, Dallas, Texas 75235, United States; Completed
Pfizer Investigational Site, Houston, Texas 77030, United States; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: December 2007
Last updated: February 5, 2013
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