High Dose of Activated Recombinant Human Factor VII for Treatment of Mild/Moderate Joint Bleeds in Haemophilia Patients With Inhibitors

Phase 4

Completed

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

• Registration Number: NCT00571584
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively
• A history of 3 or more joint bleeds during the last 12 months

Exclusion Criteria

• Joint bleeding within 7 days prior to trial start
• Treatment for bleeds within the last 5 days prior to trial start
• Clinically relevant coagulation disorders other than congenital haemophilia A or B

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global treatment response of the patient by an algorithm based pain and joint mobility assessments

Secondary Outcome Measures

Name	Time	Method
Pain assessment
Mobility assessment
Adverse events
Circumference of joint

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Sheffield, United Kingdom