NCT00037544

Brief Summary

To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

First QC Date

May 17, 2002

Last Update Submit

April 18, 2008

Conditions

Hemophilia A

Keywords

SevereHemophiliaA

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 less than or equal to 2% at local laboratory)
  • Previously treated patients with greater than or equal to 250 exposure days to any Factor VIII product
  • Age greater than or equal to 12 years
  • History of prophylaxis dosing at least twice per week on any Factor VIII product for at least 3 consecutive months within the 2 years prior to study enrollment unless the patient completed the previous pharmacokinetic study
  • Adequate laboratory results

You may not qualify if:

  • Presence of any bleeding disorder in addition to hemophilia A
  • Concomitant therapy with immunosuppressive drugs
  • Current or historical Factor VIII inhibitor
  • Treatment with any investigational drug or device within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemophilia ALymphoma, Follicular

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 AbnormalitiesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

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
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2002

First Posted

May 20, 2002

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

April 22, 2008

Record last verified: 2008-04