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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00108758
Other study ID # F7HAEM-1505
Secondary ID
Status Completed
Phase Phase 2
First received April 18, 2005
Last updated January 11, 2017
Start date March 2004
Est. completion date November 2005

Study information

Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Bulgaria: Ministry of HealthSpain: Spanish Agency of MedicinesRussia: Pharmacological Committee, Ministry of HealthTurkey: Ministry of HealthBrazil: National Health Surveillance AgencyPoland: Ministry of HealthRomania: State Institute for Drug ControlSouth Africa: Medicines Control CouncilArgentina: Administracion Nacional de Medicamentos, Alimentos y TecnologiaPhilippines: Bureau of Food and DrugsUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Drug:
activated recombinant human factor VII


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  France,  Philippines,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Turkey, 

References & 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. — View Citation

Outcome

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
See also
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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
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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
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