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NCT00108797 Clinical Trial

Trial of NovoSeven® in Haemophilia - Joint Bleeds

Congenital Bleeding Disorder Clinical Trial

Official title:
NovoSeven® (rFVIIa) by Single Dose for Home Treatment of Joint Bleeds in Haemophilia Patients With Inhibitors: A Pilot, Double-Blind Study Versus Standard Multiple Doses of NovoSeven® and Open-Label FEIBA®

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00108797
Other study ID # F7HAEM-2068
Secondary ID
Status Completed
Phase Phase 4
First received April 18, 2005
Last updated January 11, 2017
Start date September 2001
Est. completion date February 2006

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender Male
Age group N/A to 20 Years
Eligibility Inclusion Criteria:

- Diagnosis of hemophilia A or B with inhibitors to factor VIII or IX, respectively

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• eptacog alfa (activated)

• Feiba VH

Locations
Country Name City State
United States Novo Nordisk Investigational Site Aurora Colorado
United States Novo Nordisk Investigational Site Berkeley California
United States Novo Nordisk Investigational Site Boston Massachusetts
United States Novo Nordisk Investigational Site Chapel Hill North Carolina
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Detroit Michigan
United States Novo Nordisk Investigational Site Hershey Pennsylvania
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 Little Rock Arkansas
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Minneapolis Minnesota
United States Novo Nordisk Investigational Site New Brunswick New Jersey
United States Novo Nordisk Investigational Site New Orleans Louisiana
United States Novo Nordisk Investigational Site New York New York
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

Country where clinical trial is conducted

United States, 

References & Publications (1)

Young G, Shafer FE, Rojas P, Seremetis S. Single 270 microg kg(-1)-dose rFVIIa vs. standard 90 microg kg(-1)-dose rFVIIa and APCC for home treatment of joint bleeds in haemophilia patients with inhibitors: a randomized comparison. Haemophilia. 2008 Mar;14 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison with FEIBA on review of pain, joint mobility and circumference after 1, 3, 6, and 9 hours of treatment, respectively No
Secondary Safety variables 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 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 NCT01230021 - Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency Phase 3
Completed NCT01220141 - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B N/A

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