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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