Trial of NovoSeven® in Haemophilia - Joint Bleeds
NovoSeven® (rFVIIa) by Single Dose for Home Treatment of Joint Bleeds in Haemophilia Patients With Inhibitors: A Pilot, Double-Blind Study Versus Standard Multiple Doses of NovoSeven® and Open-Label FEIBA®
1 other identifier
interventional
42
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2001
Longer than P75 for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
April 18, 2005
CompletedFirst Posted
Study publicly available on registry
April 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedJanuary 12, 2017
January 1, 2017
4.4 years
April 18, 2005
January 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison with FEIBA on review of pain, joint mobility and circumference
after 1, 3, 6, and 9 hours of treatment, respectively
Secondary Outcomes (1)
Safety variables
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of hemophilia A or B with inhibitors to factor VIII or IX, respectively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (20)
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
Related Publications (1)
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.
PMID: 18081834RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2005
First Posted
April 19, 2005
Study Start
September 1, 2001
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
January 12, 2017
Record last verified: 2017-01