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
  Purpose

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.


Condition Intervention Phase
Hemophilia A
Drug: moroctocog alfa (AF-CC)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
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%)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: August 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1
Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2.
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
Experimental: Sequence 2
Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2.
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579903

Locations
Bulgaria
Pfizer Investigational Site
Sofia, Bulgaria, 1612
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1083
United Kingdom
Pfizer Investigational Site
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01579903     History of Changes
Other Study ID Numbers: B1831077
Study First Received: April 16, 2012
Last Updated: February 7, 2013
Health Authority: European Union: European Medicines Agency

Keywords provided by Pfizer:
Hemophilia A
moroctocog alfa (AF-CC)
ReFacto AF
dual-chamber syringe
bioavailability

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014