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

February 9, 2017 updated by: Novo Nordisk A/S

Multi-centre, Open-label, Non-randomised Single Dose Trial Investigating the Pharmacokinetics of N8 in Japanese Subjects With Haemophilia A

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Itabashi-ku, Tokyo, Japan, 173 8606
        • Novo Nordisk Investigational Site
      • Kashihara-shi, Nara, Japan, 634 8522
        • Novo Nordisk Investigational Site
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Novo Nordisk Investigational Site
      • Shinjuku-ku, Tokyo, Japan, 160 0023
        • Novo Nordisk Investigational Site
      • Shizuoka-shi, Shizuoka, Japan, 4208660
        • Novo Nordisk Investigational Site
      • Suginami-ku, Tokyo, Japan, 1670035
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: recombinant factor VIII (N8)
Drug: turoctocog alfa
Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.
Other Names:
  • recombinant factor VIII
  • N8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incremental recovery
Time Frame: Infusion, 30 minutes
Infusion, 30 minutes
Area under the curve
Time Frame: Infusion, 30 minutes
Infusion, 30 minutes
In vivo t1/2
Time Frame: Infusion, 30 minutes
Infusion, 30 minutes
Total clearance (CL)
Time Frame: Infusion, 30 minutes
Infusion, 30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 9, 2010

First Submitted That Met QC Criteria

November 9, 2010

First Posted (Estimate)

November 10, 2010

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7008-3600
  • U1111-1117-1286 (Other Identifier: WHO)
  • JapicCTI-101346 (Other Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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