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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01365520
First received: May 30, 2011
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  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 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: NNC 0155-0000-0004
 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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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: A Drug: NNC 0155-0000-0004
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
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
Investigators
Study Director: Judi Møss Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, 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 29, 2012
Health Authority: United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
Malaysia: Ministry of Health

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia A
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 May 21, 2013