Trial of NovoSeven® in Haemophilia – Joint Bleeds

Overview

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.

Full Title of Study: “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®”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2006

Interventions

  • Drug: eptacog alfa (activated)
  • Drug: Feiba VH

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Safety variables

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: Male

Minimum Age: N/A

Maximum Age: 20 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novo Nordisk A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

Citations Reporting on Results

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.

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