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CompletedNCT00108797Updated Jan 12, 2017

Trial of NovoSeven® in Haemophilia - Joint Bleeds

A Phase 4 interventional study of eptacog alfa (activated) and Feiba VH in Congenital Bleeding Disorder, Haemophilia A With Inhibitors and Haemophilia B With Inhibitors, sponsored by Novo Nordisk A/S. Completed at 20 sites in United States. Open to male participants aged Up to 20 Years. Per ClinicalTrials.gov, last updated 2017-01-12.

Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
Up to 20 Years
Sex
Male
01

Study summary

This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.

02

Conditions studied

  • Congenital Bleeding Disorder
  • Haemophilia A With Inhibitors
  • Haemophilia B With Inhibitors
03

In context

Hemostatic Disorders

503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.

This study's enrollment of 42 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

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

04

Who can participate

Ages eligible
Up to 20 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Diagnosis of hemophilia A or B with inhibitors to factor VIII or IX, respectively
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Interventions

  • Drugeptacog alfa (activated)

    Also known as: activated recombinant human factor VII

  • DrugFeiba VH
06

What researchers measure

Primary outcomes

  1. Comparison with FEIBA on review of pain, joint mobility and circumference

    Time frame: after 1, 3, 6, and 9 hours of treatment, respectively

Secondary outcomes

  1. Safety variables

07

Study locations

20 sites
  • Novo Nordisk Investigational Site
    Little Rock, Arkansas 72202, United States
  • Novo Nordisk Investigational Site
    Berkeley, California 94704, United States
  • Novo Nordisk Investigational Site
    Los Angeles, California 90027, United States
  • Novo Nordisk Investigational Site
    Aurora, Colorado 80010, United States
  • Novo Nordisk Investigational Site
    Chicago, Illinois 60612, United States
  • Novo Nordisk Investigational Site
    Indianapolis, Indiana 46260, United States
  • Novo Nordisk Investigational Site
    Iowa City, Iowa 52242, United States
  • Novo Nordisk Investigational Site
    New Orleans, Louisiana 70112, United States
  • Novo Nordisk Investigational Site
    Boston, Massachusetts 02115, United States
  • Novo Nordisk Investigational Site
    Detroit, Michigan 48201, United States
  • Novo Nordisk Investigational Site
    Minneapolis, Minnesota 55404, United States
  • Novo Nordisk Investigational Site
    New Brunswick, New Jersey 08903, United States
  • Novo Nordisk Investigational Site
    Newark, New Jersey 07112, United States
  • Novo Nordisk Investigational Site
    New York, New York 10029-6574, United States
  • Novo Nordisk Investigational Site
    Chapel Hill, North Carolina 27599-7220, United States
  • Novo Nordisk Investigational Site
    Cincinnati, Ohio 45229, United States
  • Novo Nordisk Investigational Site
    Hershey, Pennsylvania 17033, United States
  • Novo Nordisk Investigational Site
    Philadelphia, Pennsylvania 19104, United States
  • Novo Nordisk Investigational Site
    Philadelphia, Pennsylvania 19134-1095, United States
  • Novo Nordisk Investigational Site
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Young G, Shafer FE, Rojas P, Seremetis S. Single 270 microg kg(-1)-dose rFVIIa vs. standard 90 microg kg(-1)-dose rFVIIa and APCC for home treatment of joint bleeds in haemophilia patients with inhibitors: a randomized comparison. Haemophilia. 2008 Mar;14(2):287-94. doi: 10.1111/j.1365-2516.2007.01601.x. Epub 2007 Dec 10. PubMed 18081834 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00108797
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Apr 19, 2005
Start date
Sep 2001
Primary completion
Feb 2006
Completion
Feb 2006
Last update
Jan 12, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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