Congenital Bleeding Disorder Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | November 2005 |
| Est. primary completion date | November 2005 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 2 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Novo Nordisk Investigational Site | Ciudad Autónoma de Bs. As. | |
| Brazil | Novo Nordisk Investigational Site | Belo Horizonte | |
| Brazil | Novo Nordisk Investigational Site | Campinas | Sao Paulo |
| Brazil | Novo Nordisk Investigational Site | Recife | |
| Brazil | Novo Nordisk Investigational Site | Ribeirao Preto | |
| Brazil | Novo Nordisk Investigational Site | Rio de Janeiro | |
| Bulgaria | Novo Nordisk Investigational Site | Sofia | |
| France | Novo Nordisk Investigational Site | Kremlin-Bicêtre | |
| France | Novo Nordisk Investigational Site | Lille | |
| France | Novo Nordisk Investigational Site | Paris | |
| Philippines | Novo Nordisk Investigational Site | Manila | |
| Poland | Novo Nordisk Investigational Site | Gdansk | |
| Poland | Novo Nordisk Investigational Site | Lublin | |
| Poland | Novo Nordisk Investigational Site | Warszawa | |
| Poland | Novo Nordisk Investigational Site | Warszawa | |
| Romania | Novo Nordisk Investigational Site | Bucharest | |
| Romania | Novo Nordisk Investigational Site | Timisoara | Timis |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| South Africa | Novo Nordisk Investigational Site | Johannesburg | Gauteng |
| Spain | Novo Nordisk Investigational Site | Madrid | |
| Spain | Novo Nordisk Investigational Site | Santander | |
| Spain | Novo Nordisk Investigational Site | Sevilla | |
| Turkey | Novo Nordisk Investigational Site | Bornova-IZMIR | |
| Turkey | Novo Nordisk Investigational Site | Capa-ISTANBUL | |
| United States | Novo Nordisk Investigational Site | Berkeley | California |
| United States | Novo Nordisk Investigational Site | Boston | Massachusetts |
| United States | Novo Nordisk Investigational Site | Chicago | Illinois |
| United States | Novo Nordisk Investigational Site | Detroit | Michigan |
| United States | Novo Nordisk Investigational Site | Houston | Texas |
| United States | Novo Nordisk Investigational Site | Indianapolis | Indiana |
| United States | Novo Nordisk Investigational Site | Iowa City | Iowa |
| United States | Novo Nordisk Investigational Site | Los Angeles | California |
| United States | Novo Nordisk Investigational Site | New Hyde Park | New York |
| United States | Novo Nordisk Investigational Site | New Orleans | Louisiana |
| United States | Novo Nordisk Investigational Site | Newark | New Jersey |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Argentina, Brazil, Bulgaria, France, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Turkey,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction of bleeds | During 3 months treatment period as compared to 3 months observation period | No | |
| Secondary | Efficacy variables | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00978380 -
Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725
|
Phase 3 | |
| Completed |
NCT02568202 -
Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)
|
N/A | |
| Completed |
NCT01949792 -
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
|
Phase 1 | |
| Completed |
NCT01205724 -
Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A
|
Phase 1 | |
| Completed |
NCT01562587 -
Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State
|
Phase 1 | |
| Completed |
NCT00108797 -
Trial of NovoSeven® in Haemophilia - Joint Bleeds
|
Phase 4 | |
| Completed |
NCT01493778 -
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
|
Phase 3 | |
| Completed |
NCT02490787 -
Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects
|
Phase 1 | |
| Completed |
NCT00951405 -
Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors
|
Phase 2 | |
| Completed |
NCT01876745 -
A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
|
N/A | |
| Completed |
NCT02920398 -
A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A
|
Phase 1 | |
| Completed |
NCT00984126 -
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
|
Phase 3 | |
| Completed |
NCT01228669 -
Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B
|
Phase 1 | |
| Completed |
NCT01988532 -
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
|
N/A | |
| Completed |
NCT01234545 -
Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors
|
N/A | |
| Completed |
NCT01779921 -
Treatment of Congenital Factor VII Deficiency
|
N/A | |
| Completed |
NCT01563471 -
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT02941354 -
Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A
|
Phase 1 | |
| Completed |
NCT02241694 -
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives
|
N/A | |
| Completed |
NCT01220141 -
Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B
|
N/A |