A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543

Phase 1

Completed

• Conditions: Haemophilia A; Congenital Bleeding Disorder
• Interventions: Drug: turoctocog alfa

• Registration Number: NCT01238367
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Japanese subjects who have completed NN7008-3543
• No detectable inhibitors to factor VIII

Exclusion Criteria

• Congenital or acquired coagulation disorders other than haemophilia A
• Planned surgery during the trial period
• Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
recombinant factor VIII (N8)	turoctocog alfa	-

Primary Outcome Measures

Name	Time	Method
In vivo t1/2	Infusion, 30 minutes
Total clearance (CL)	Infusion, 30 minutes
Area under the curve	Infusion, 30 minutes
Incremental recovery	Infusion, 30 minutes

Secondary Outcome Measures

Name	Time	Method
Maximal concentration	at 15 minutes
Area under the curve	from time zero to last
Number of adverse events	from day -1 to day 3 (end of trial)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Suginami-ku, Tokyo, Japan