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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01365520
First received: May 30, 2011
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Malaysia
Kuala Lumpur, Malaysia, 50400
United Kingdom
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Judi Møss Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

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: June 10, 2013
Health Authority: United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
Malaysia: Ministry of Health

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014