Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia
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
1 other identifier
interventional
23
12 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2004
37 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
March 1, 2004
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
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedJanuary 12, 2017
January 1, 2017
1.7 years
April 18, 2005
January 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of bleeds
During 3 months treatment period as compared to 3 months observation period
Secondary Outcomes (1)
Efficacy variables
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively
You may not qualify if:
- Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (37)
Novo Nordisk Investigational Site
Berkeley, California, 94704, United States
Novo Nordisk Investigational Site
Los Angeles, California, 90027, 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, 70112-2699, United States
Novo Nordisk Investigational Site
Boston, Massachusetts, 02115, United States
Novo Nordisk Investigational Site
Detroit, Michigan, 48201, United States
Novo Nordisk Investigational Site
Newark, New Jersey, 07112, United States
Novo Nordisk Investigational Site
New Hyde Park, New York, 11042, 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
Novo Nordisk Investigational Site
Ciudad Autónoma de Bs. As., C1425ASU, Argentina
Novo Nordisk Investigational Site
Rio de Janeiro, Rio de Janeiro, 20211-030, Brazil
Novo Nordisk Investigational Site
Campinas, São Paulo, 13081970, Brazil
Novo Nordisk Investigational Site
Belo Horizonte, 10130-110, Brazil
Novo Nordisk Investigational Site
Recife, 52011-000, Brazil
Novo Nordisk Investigational Site
Ribeirão Preto, 14051-140, Brazil
Novo Nordisk Investigational Site
Sofia, 1756, Bulgaria
Novo Nordisk Investigational Site
Le Kremlin-Bicêtre, 94270, France
Novo Nordisk Investigational Site
Lille, 59037, France
Novo Nordisk Investigational Site
Paris, 75015, France
Novo Nordisk Investigational Site
Manila, Philippines
Novo Nordisk Investigational Site
Gdansk, 80-952, Poland
Novo Nordisk Investigational Site
Lublin, 20-954, Poland
Novo Nordisk Investigational Site
Warsaw, 00-576, Poland
Novo Nordisk Investigational Site
Warsaw, 00-791, Poland
Novo Nordisk Investigational Site
Timișoara, Timiș County, 300011, Romania
Novo Nordisk Investigational Site
Bucharest, 022328, Romania
Novo Nordisk Investigational Site
Moscow, 105077, Russia
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2193, South Africa
Novo Nordisk Investigational Site
Madrid, 28046, Spain
Novo Nordisk Investigational Site
Santander, 39008, Spain
Novo Nordisk Investigational Site
Seville, 41013, Spain
Novo Nordisk Investigational Site
Bornova-IZMIR, 35100, Turkey (Türkiye)
Novo Nordisk Investigational Site
Capa-ISTANBUL, 35100, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 17723130RESULT
Related Links
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2005
First Posted
April 19, 2005
Study Start
March 1, 2004
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
January 12, 2017
Record last verified: 2017-01