Trial of NovoSeven® in Haemophilia - Joint Bleeds

January 11, 2017 updated by: Novo Nordisk A/S

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®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arkansas
  - Little Rock, Arkansas, United States, 72202
    - Novo Nordisk Investigational Site
- California
  - Berkeley, California, United States, 94704
    - Novo Nordisk Investigational Site
  - Los Angeles, California, United States, 90027
    - Novo Nordisk Investigational Site
- Colorado
  - Aurora, Colorado, United States, 80010
    - Novo Nordisk Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60612
    - Novo Nordisk Investigational Site
- Indiana
  - Indianapolis, Indiana, United States, 46260
    - Novo Nordisk Investigational Site
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Novo Nordisk Investigational Site
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Novo Nordisk Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Novo Nordisk Investigational Site
- Michigan
  - Detroit, Michigan, United States, 48201
    - Novo Nordisk Investigational Site
- Minnesota
  - Minneapolis, Minnesota, United States, 55404
    - Novo Nordisk Investigational Site
- New Jersey
  - New Brunswick, New Jersey, United States, 08903
    - Novo Nordisk Investigational Site
  - Newark, New Jersey, United States, 07112
    - Novo Nordisk Investigational Site
- New York
  - New York, New York, United States, 10029-6574
    - Novo Nordisk Investigational Site
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599-7220
    - Novo Nordisk Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - Novo Nordisk Investigational Site
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Novo Nordisk Investigational Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Novo Nordisk Investigational Site
  - Philadelphia, Pennsylvania, United States, 19134-1095
    - Novo Nordisk Investigational Site
- Texas
  - Houston, Texas, United States, 77030
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison with FEIBA on review of pain, joint mobility and circumference Time Frame: after 1, 3, 6, and 9 hours of treatment, respectively	after 1, 3, 6, and 9 hours of treatment, respectively

Secondary Outcome Measures

Outcome Measure
Safety variables

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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(2):287-94. doi: 10.1111/j.1365-2516.2007.01601.x. Epub 2007 Dec 10.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)