Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)

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NCT01579903

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Study Location
Pfizer Investigational Site
Sofia, , 1612, Bulgaria
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Contact
1-800-718-1021
[email protected]
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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
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male patients at least 18 years old with severe or moderately severe hemophilia A (facto VIII concentration less than or equal to 2%).

- Negative test for facto VIII inhibitor.

- If applicable, HIV or hepatitis treatment is stable at the time of enrollment.

- Ability to abstain from use of FVIII products for 72 hours at a time.

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


- History of any positive test result for factor VIII inhibitor.


- Presence of any bleeding disorder in addition to Hemophilia A.


- Body weight less than 50 kg.


- History of alcoholism.


- Treatment with investigational drug or device within 30 days prior to the Screening
visit.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)
Official Title  ICMJE An Open-Label, Randomized, Two-period Crossover Study To Compare Relative Bioavailability of Two Formulations of Moroctocog Alfa (Af-cc) In Subjects With Moderately Severe Or Severe Hemophilia A (FVIII:C </=2%)
Brief Summary This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.
Detailed Description This study is being conducted in order to satisfy a post-approval EMA commitment to compare the pharmacokinetics of the 2 dose presentations used in this study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Hemophilia A
Intervention  ICMJE
  • Drug: moroctocog alfa (AF-CC)
    Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent); Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes
  • Drug: moroctocog alfa (AF-CC)
    Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes; Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent)
Study Arms  ICMJE
  • Experimental: Sequence 1
    Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2.
    Intervention: Drug: moroctocog alfa (AF-CC)
  • Experimental: Sequence 2
    Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2.
    Intervention: Drug: moroctocog alfa (AF-CC)
Publications * Shafer F, Charnigo RJ, Plotka A, Baumann J, Liang Y, Korth-Bradley J. Assessment of relative bioavailability of two presentations of moroctocog alfa (AF-CC) in subjects with moderately severe or severe hemophilia A. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):237-41. doi: 10.1002/cpdd.168. Epub 2014 Oct 27.

*   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: February 7, 2013)		16
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2012)		18
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male patients at least 18 years old with severe or moderately severe hemophilia A (facto VIII concentration less than or equal to 2%).
  • Negative test for facto VIII inhibitor.
  • If applicable, HIV or hepatitis treatment is stable at the time of enrollment.
  • Ability to abstain from use of FVIII products for 72 hours at a time.

Exclusion Criteria:

  • History of any positive test result for factor VIII inhibitor.
  • Presence of any bleeding disorder in addition to Hemophilia A.
  • Body weight less than 50 kg.
  • History of alcoholism.
  • Treatment with investigational drug or device within 30 days prior to the Screening visit.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Hungary,   United Kingdom
Removed Location Countries Belgium,   Greece,   Poland
 
Administrative Information
NCT Number  ICMJE NCT01579903
Other Study ID Numbers  ICMJE B1831077
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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 February 2013

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