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Completed

NCT Number: NCT01579903

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

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Sofia, Bulgaria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

moroctocog alfa (AF-CC)

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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%)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2012
Registry last updated
Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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