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CompletedNCT00037544Updated Apr 22, 2008

Study Evaluating ReFacto AF in Severe Hemophilia A

A Phase 3 interventional study of ReFacto AF in Hemophilia A, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2008-04-22.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Ages
12 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Hemophilia A

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Keywords

  • Severe
  • Hemophilia
  • A
03

In context

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

Browse Hemophilia A studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment

Interventions

  • DrugReFacto AF
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00037544
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
May 20, 2002
Primary completion
Aug 2004
Completion
Aug 2004
Last update
Apr 22, 2008

Study contacts

Medical Monitor, MD
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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