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

NCT01238367 | Completed Phase 1

• 3 other identifiers: NN7008-3600U1111-1117-1286JapicCTI-101346
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Congenital Bleeding Disorder; Haemophilia A

Outcome Measures

Primary Outcomes (4)

• Area under the curve

  Infusion, 30 minutes

• Incremental recovery

  Infusion, 30 minutes

• In vivo t1/2

  Infusion, 30 minutes

• Total clearance (CL)

  Infusion, 30 minutes

Secondary Outcomes (3)

• Maximal concentration

  at 15 minutes

• Area under the curve

  from time zero to last

• Number of adverse events

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

Study Arms (1)

recombinant factor VIII (N8)

EXPERIMENTAL

Drug: turoctocog alfa

Interventions

turoctocog alfa DRUG

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

Also known as: N8, recombinant factor VIII

recombinant factor VIII (N8)

Eligibility Criteria

• Age: 12 Years - 66 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (6)

Novo Nordisk Investigational Site

Itabashi-ku, Tokyo, 173 8606, Japan

Location

Novo Nordisk Investigational Site

Kashihara-shi, Nara, 634 8522, Japan

Location

Novo Nordisk Investigational Site

Maebashi-shi, Gunma, 371-8511, Japan

Location

Novo Nordisk Investigational Site

Shinjuku-ku, Tokyo, 160 0023, Japan

Location

Novo Nordisk Investigational Site

Shizuoka-shi, Shizuoka, 4208660, Japan

Location

Novo Nordisk Investigational Site

Suginami-ku, Tokyo, 1670035, Japan

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; Factor VIII

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

Intervention Hierarchy (Ancestors)

Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

JP (6)