Clinical trial NCT00108797: Trial of NovoSeven® in Haemophilia - Joint Bleeds
Official title: 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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-04-19
Enrollment: 42
Sex: MALE
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Comparison with FEIBA on review of pain, joint mobility and circumference
timeFrame: after 1, 3, 6, and 9 hours of treatment, respectively
Secondary outcomes:
measure: Safety variables
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Arkansas
city: Berkeley
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Aurora
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: New Orleans
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Minnesota
city: New Brunswick
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Newark
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Hershey
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.