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

NCT01365520 | Completed Phase 1

• 3 other identifiers: NN7008-38932010-023921-39U1111-1118-2228
• Study Type: interventional
• Target: 4
• Locations: 2 countries
• Sites: 3

Brief Summary

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).

Conditions

Congenital Bleeding Disorder; Haemophilia A

Outcome Measures

Primary Outcomes (4)

• Area under the curve

  Infusion, 48 hours

• Incremental recovery

  Infusion, 30 minutes

• In vivo t1/2

  Infusion, 48 hours

• Total clearance (CL)

  Infusion, 48 hours

Secondary Outcomes (2)

• Maximal concentration (Cmax)

  15 minutes after trial drug administration

• Number of adverse events

  up to 48 hours after trial drug administration

Study Arms (1)

N8

EXPERIMENTAL

Drug: turoctocog alfa

Interventions

turoctocog alfa DRUG

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.

N8

Eligibility Criteria

• Age: 12 Years - 56 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (3)

Novo Nordisk Investigational Site

Kuala Lumpur, 50400, Malaysia

Location

Novo Nordisk Investigational Site

London, NW3 2QG, United Kingdom

Location

Novo Nordisk Investigational Site

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25495795 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia A

Interventions

recombinant factor VIII N8

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 3, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

MY (1); GB (2)