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%)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01579903

Enrollment

Registered

2012-04-18

Start date

2012-08-31

Completion date

2013-01-31

Last updated

2013-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Hemophilia A, moroctocog alfa (AF-CC), ReFacto AF, dual-chamber syringe, bioavailability

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.

Interventions

DRUGmoroctocog 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (secondary PK parameters include: tmax, λz, t1/2, CL, Vss, and FVIII Recovery)	Periods 1 and 2, Day 1 through Day 4

Countries

Bulgaria, Hungary, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026