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Congenital Bleeding DisorderPhase 1NCT01238367

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

A Phase 1 study testing turoctocog alfa in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 66 years, men only
Conditions the study is for
Congenital Bleeding Disorder, Haemophilia A
What is being tested?
turoctocog alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
6 sitesJapan
Study dates
Nov 2010to Oct 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 66 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Japan6 sites

  • Novo Nordisk Investigational Site

    Itabashi-ku, Tokyo, 173 8606

  • Novo Nordisk Investigational Site

    Kashihara-shi, Nara, 634 8522

  • Novo Nordisk Investigational Site

    Maebashi-shi, Gunma, 371-8511

  • Novo Nordisk Investigational Site

    Shinjuku-ku, Tokyo, 160 0023

  • Novo Nordisk Investigational Site

    Shizuoka-shi, Shizuoka, 4208660

  • Novo Nordisk Investigational Site

    Suginami-ku, Tokyo, 1670035

Other trials in Japan

About this study

Official title: 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.

Being tested
turoctocog alfa
Medical subject headings
Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • turoctocog alfaDrug

    Also called N8, recombinant factor VIII

    Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.

Study groups in NCT01238367
Study groupRoleWhat they receive
recombinant factor VIII (N8)ExperimentalNot described
Receives: Drug: turoctocog alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve

    Measured: Infusion, 30 minutes

  2. Incremental recovery

    Measured: Infusion, 30 minutes

  3. In vivo t1/2

    Measured: Infusion, 30 minutes

  4. Total clearance (CL)

    Measured: Infusion, 30 minutes

Secondary outcomes (3)

  1. Maximal concentration

    Measured: at 15 minutes

  2. Area under the curve

    Measured: from time zero to last

  3. Number of adverse events

    Measured: from day -1 to day 3 (end of trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01238367
Sponsor's protocol ID
NN7008-3600
Other IDs
U1111-1117-1286, JapicCTI-101346
Status last verified
Feb 2017
First submitted
9 Nov 2010
Last updated
10 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • Jimenez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Moss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight(R)), in patients with hemophilia A. J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13.

    PubMed 25495795

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing turoctocog alfa in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve (time frame: Infusion, 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01238367, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.

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