NCT00093210

Brief Summary

The primary objective of this clinical research study is to establish the bioequivalence of 2 treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.

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

October 4, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

October 4, 2004

Last Update Submit

December 3, 2007

Conditions

Hemophilia B

Interventions

rFIXDRUG
rFIX-RDRUG

Eligibility Criteria

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

You may qualify if:

  • Moderate to severe hemophilia B (FIX: C ≤2%)
  • Previously treated patients (PTPs) with ≥150 documented exposure days
  • Age ≥ 12 years (US sites only)

You may not qualify if:

  • Detectable factor IX inhibitor defined as ≥0.6 Bethesda Units for pooled plasma reported by the local laboratory (family history of inhibitors will not exclude the patient)
  • Patient history of factor IX inhibitor replacement therapy
  • Patient unable to be off factor IX replacement therapy for at least 5 days without bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Wojciechowski J, Gaitonde P, Hughes JH, Ravva P. Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B. Clin Pharmacokinet. 2025 Oct;64(10):1531-1548. doi: 10.1007/s40262-025-01535-y. Epub 2025 Aug 1.

    PMID: 40750723DERIVED

  • Rendo P, Smith L, Lee HY, Shafer F. Nonacog alfa: an analysis of safety data from six prospective clinical studies in different patient populations with haemophilia B treated with different therapeutic modalities. Blood Coagul Fibrinolysis. 2015 Dec;26(8):912-8. doi: 10.1097/MBC.0000000000000359.

    PMID: 26196195DERIVED

MeSH Terms

Conditions

Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

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
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2004

First Posted

October 7, 2004

Study Completion

September 1, 2005

Last Updated

December 5, 2007

Record last verified: 2007-12