NCT00038935

Brief Summary

The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2002

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

First QC Date

June 5, 2002

Last Update Submit

April 18, 2008

Conditions

Hemophilia A

Keywords

Hemophilia

Interventions

ReFacto AFDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Severe hemophilia A (FVIII:C \< 1% at local laboratory)
  • Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product
  • Age greater than or equal to 12 years\\

You may not qualify if:

  • The presence of any bleeding disorder in addition to hemophilia A
  • Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use)
  • History of detectable factor VIII inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Korth-Bradley J, Rupon J, Plotka A, Charnigo R, Rendo P. Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF-CC) in Subjects With Severe Hemophilia A. Clin Transl Sci. 2018 May;11(3):283-288. doi: 10.1111/cts.12544. Epub 2018 Mar 25.

    PMID: 29575770DERIVED

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2002

First Posted

June 7, 2002

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

April 22, 2008

Record last verified: 2008-04