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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: May 30, 2011
Last updated: July 7, 2015
Last verified: July 2015
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).

Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Drug: turoctocog alfa
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients With Haemophilia A

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the curve [ Time Frame: Infusion, 48 hours ] [ Designated as safety issue: No ]
  • Incremental recovery [ Time Frame: Infusion, 30 minutes ] [ Designated as safety issue: No ]
  • In vivo t1/2 [ Time Frame: Infusion, 48 hours ] [ Designated as safety issue: No ]
  • Total clearance (CL) [ Time Frame: Infusion, 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximal concentration (Cmax) [ Time Frame: 15 minutes after trial drug administration ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: up to 48 hours after trial drug administration ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   12 Years to 56 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01365520

Kuala Lumpur, Malaysia, 50400
United Kingdom
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01365520     History of Changes
Other Study ID Numbers: NN7008-3893  2010-023921-39  U1111-1118-2228 
Study First Received: May 30, 2011
Last Updated: July 7, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Malaysia: Ministry of Health

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemophilia A
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2016