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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01579903
First received: April 16, 2012
Last updated: February 7, 2013
Last verified: February 2013
History of Changes

April 16, 2012
February 7, 2013
August 2012
January 2013   (final data collection date for primary outcome measure)
Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (primary PK parameters include: Cmax, AUClast, and AUCinf) [ Time Frame: Periods 1 and 2, Day 1 through 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01579903 on ClinicalTrials.gov Archive Site
Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (secondary PK parameters include: tmax, λz, t1/2, CL, Vss, and FVIII Recovery) [ Time Frame: Periods 1 and 2, Day 1 through Day 4 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)
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%)

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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Hemophilia A
  • 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)
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2013
January 2013   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Hungary,   United Kingdom
 
NCT01579903
B1831077
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

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