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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229 United States
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
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

- 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.

NCT00543439
Pfizer
Active, not recruiting
Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII

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Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemophilia A
  • 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
  • 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)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
66
April 23, 2018
April 23, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
6 Months to 15 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Colombia,   Croatia,   Jordan,   Mexico,   New Zealand,   Oman,   Peru,   Poland,   Romania,   Turkey,   United States
Germany,   Italy,   Lebanon,   Spain
 
NCT00543439
3082B2-313
B1831001 ( Other Identifier: Alias Study Number )
2006-005575-17 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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