Trial of NovoSeven® in Haemophilia - Joint Bleeds

Phase 4

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

• Registration Number: NCT00108797
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2005-04-18
• Study First Submitted QC: 2005-04-18
• Study First Posted: 2005-04-19
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety variables

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Houston, Texas, United States