Clinical trial NCT00108758: Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia
Official title: Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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: 23
Sex: MALE
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

Exclusion Criteria:

* Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.

Primary outcomes:
measure: Reduction of bleeds
timeFrame: During 3 months treatment period as compared to 3 months observation period
Secondary outcomes:
measure: Efficacy variables
Other outcomes:
Locations:
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: 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: Newark
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: New Hyde Park
country: United States
facility: Novo Nordisk Investigational Site
state: New York
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
city: Ciudad Autónoma de Bs. As.
country: Argentina
facility: Novo Nordisk Investigational Site
city: Campinas
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Belo Horizonte
country: Brazil
facility: Novo Nordisk Investigational Site
city: Recife
country: Brazil
facility: Novo Nordisk Investigational Site
city: Ribeirao Preto
country: Brazil
facility: Novo Nordisk Investigational Site
city: Rio de Janeiro
country: Brazil
facility: Novo Nordisk Investigational Site
city: Sofia
country: Bulgaria
facility: Novo Nordisk Investigational Site
city: Kremlin-Bicêtre
country: France
facility: Novo Nordisk Investigational Site
city: Lille
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Manila
country: Philippines
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Lublin
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Timisoara
country: Romania
facility: Novo Nordisk Investigational Site
state: Timis
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Santander
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Bornova-IZMIR
country: Turkey
facility: Novo Nordisk Investigational Site
city: Capa-ISTANBUL
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Konkle BA, Ebbesen LS, Erhardtsen E, Bianco RP, Lissitchkov T, Rusen L, Serban MA. Randomized, prospective clinical trial of recombinant factor VIIa for secondary prophylaxis in hemophilia patients with inhibitors. J Thromb Haemost. 2007 Sep;5(9):1904-13. doi: 10.1111/j.1538-7836.2007.02663.x.