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NCT00571584 Clinical Trial

High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

Congenital Bleeding Disorder Clinical Trial

Official title:
rFVIIa (NovoSeven®) for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors: A Double-blind Study of a Single High Dose Versus Standard Multiple Doses of rFVIIa

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00571584
Other study ID # F7HEAM-1510
Secondary ID
Status Completed
Phase Phase 4
First received December 11, 2007
Last updated January 11, 2017
Start date November 2002
Est. completion date March 2004

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)United Kingdom: Medicines and Healthcare Products RegulatoryHungary: National Institute of PharmacyIsrael: Israeli Health Ministry Pharmaceutical AdministrationTurkey: Ministry of Health Drug and Pharmaceutical Department
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date March 2004
Est. primary completion date March 2004
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively

- A history of 3 or more joint bleeds during the last 12 months

Exclusion Criteria:

- Joint bleeding within 7 days prior to trial start

- Treatment for bleeds within the last 5 days prior to trial start

- Clinically relevant coagulation disorders other than congenital haemophilia A or B

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• activated recombinant human factor VII

Locations
Country Name City State
France Novo Nordisk Investigational Site Kremlin-Bicêtre
France Novo Nordisk Investigational Site Lille
France Novo Nordisk Investigational Site Lyon
France Novo Nordisk Investigational Site Paris
France Novo Nordisk Investigational Site Paris
Hungary Novo Nordisk Investigational Site Budapest
Israel Novo Nordisk Investigational Site Tel-Hashomer
Poland Novo Nordisk Investigational Site Poznan
Poland Novo Nordisk Investigational Site Warszawa
Poland Novo Nordisk Investigational Site Warszawa
Poland Novo Nordisk Investigational Site Wroclaw
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Valencia
Turkey Novo Nordisk Investigational Site Bornova-IZMIR
Turkey Novo Nordisk Investigational Site Capa-ISTANBUL
United Kingdom Novo Nordisk Investigational Site Birmingham
United Kingdom Novo Nordisk Investigational Site Canterbury
United Kingdom Novo Nordisk Investigational Site Sheffield

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

France,  Hungary,  Israel,  Poland,  Spain,  Turkey,  United Kingdom, 

References & Publications (1)

Kavakli K, Makris M, Zulfikar B, Erhardtsen E, Abrams ZS, Kenet G; NovoSeven trial (F7HAEM-1510) investigators.. Home treatment of haemarthroses using a single dose regimen of recombinant activated factor VII in patients with haemophilia and inhibitors. A — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Global treatment response of the patient by an algorithm based pain and joint mobility assessments No
Secondary Pain assessment No
Secondary Mobility assessment No
Secondary Circumference of joint No
Secondary Adverse events No
See also
  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 NCT01238367 - A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543 Phase 1

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