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

Hemophilia A Clinical Trial

Official title:

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%)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579903
• Other study ID #: B1831077
• Status: Completed
• Phase: Phase 1
• First received: April 16, 2012
• Last updated: February 7, 2013
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hemophilia A

Intervention

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
• 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)

Locations

Country	Name	City	State
Bulgaria	Pfizer Investigational Site	Sofia
Hungary	Pfizer Investigational Site	Budapest
United Kingdom	Pfizer Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Bulgaria,  Hungary,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (primary PK parameters include: Cmax, AUClast, and AUCinf)		Periods 1 and 2, Day 1 through 4	No
Secondary	Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (secondary PK parameters include: tmax, ?z, t1/2, CL, Vss, and FVIII Recovery)		Periods 1 and 2, Day 1 through Day 4	No

External Links

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