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

NCT00543439

Last updated date
Study Location
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Contact
1-800-718-1021

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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
6-15 months
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemophilia A
Intervention  ICMJE
  • Biological: Moroctocog alfa (AF-CC)
    On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year.
    Other Name: Xyntha
  • Biological: Moroctocog alfa (AF-CC)

    Routine prophylaxis crossover:

    45 IU/kg, administered 2 times a week for 1 year followed by 25 IU/kg administered every other day for 1 year, or, 25 IU/kg, administered every other day for 1 year, followed by 45 IU/kg, administered 2 times a week for 1 year.

    Other Name: Xyntha
Study Arms  ICMJE
  • Experimental: 1
    On-Demand therapy for 6 months, followed by Routine Prophylaxis treatment for 1 year.
    Intervention: Biological: Moroctocog alfa (AF-CC)
  • Experimental: 2
    Routine Prophylaxis Crossover
    Intervention: Biological: Moroctocog alfa (AF-CC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2017)
66
Original Enrollment  ICMJE
 (submitted: October 11, 2007)
72
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 6 Months to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Colombia,   Croatia,   Jordan,   Mexico,   New Zealand,   Oman,   Peru,   Poland,   Romania,   Turkey,   United States
Removed Location Countries Germany,   Italy,   Lebanon,   Spain
 
Administrative Information
NCT Number  ICMJE NCT00543439
Other Study ID Numbers  ICMJE 3082B2-313
B1831001 ( Other Identifier: Alias Study Number )
2006-005575-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP