A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A

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

Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients With Haemophilia A

This trial is conducted in Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

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

  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Novo Nordisk Investigational Site
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE1 7EH
        • 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 56 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%)
  • Body weight between 10 to 120 kg
  • Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086)

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products
  • Previous participation in this trial defined as withdrawal
  • Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject)
  • Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N8
Drug: turoctocog alfa
A single dose will be administered i.v. (into the vein). Subjects will be randomised to one of two lots of NNC 0155-0000-0004.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the curve
Time Frame: Infusion, 48 hours
Infusion, 48 hours
Incremental recovery
Time Frame: Infusion, 30 minutes
Infusion, 30 minutes
In vivo t1/2
Time Frame: Infusion, 48 hours
Infusion, 48 hours
Total clearance (CL)
Time Frame: Infusion, 48 hours
Infusion, 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximal concentration (Cmax)
Time Frame: 15 minutes after trial drug administration
15 minutes after trial drug administration
Number of adverse events
Time Frame: up to 48 hours after trial drug administration
up to 48 hours after trial drug administration

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

June 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 30, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 3, 2011

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

  • NN7008-3893
  • 2010-023921-39 (EudraCT Number)
  • U1111-1118-2228 (Other Identifier: WHO)

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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