Safety and Efficacy of N8 in Haemophilia A Subjects (guardian™1)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00840086
First received: February 6, 2009
Last updated: June 29, 2012
Last verified: June 2012

February 6, 2009
June 29, 2012
April 2009
September 2011   (final data collection date for primary outcome measure)
The incidence rate of N8 inhibitors [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]
Amount of N8 used and bleeding rates and response to treatment as assessed by the physician, patient or caregiver [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00840086 on ClinicalTrials.gov Archive Site
Frequency of adverse events and serious adverse events reported [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]
Inhibitor development [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of N8 in Haemophilia A Subjects
A Multi-centre, Open-label, Non-controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A

This trial is conducted in Africa, Asia, Europe, Japan, Oceania, and North and South America.

The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of recombinant factor VIII (N8) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of N8 in prevention and treatment of bleeding during surgical procedures.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia A
  • Drug: recombinant factor VIII (N8)
    Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with N8 at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.
    Other Names:
    • NN7008
    • rFVIII
  • Procedure: Blood drawn for laboratory testing
    Blood drawn for laboratory testing
Experimental: A
Interventions:
  • Drug: recombinant factor VIII (N8)
  • Procedure: Blood drawn for laboratory testing
Lentz SR, Misgav M, Ozelo M, Salek SZ, Veljkovic D, Recht M, Cerqueira M, Tiede A, Brand B, Mancuso ME, Seremetis S, Lindblom A, Martinowitz U. Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013 Sep;19(5):691-7. doi: 10.1111/hae.12159. Epub 2013 May 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe haemophilia A (FVIII level less than or equal to 1%)
  • Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
  • Subjects can have elective surgery when at least 5 subjects have been treated with N8 for a bleeding episode and 80% of these subjects have a response rated excellent or good

Exclusion Criteria:

  • Presence of any bleeding disorder in addition to haemophilia A
  • Inhibitor titer greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
  • Abnormal renal function tests
  • Known hypersensitivity
Male
12 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Croatia,   Germany,   Israel,   Italy,   Japan,   Malaysia,   Russian Federation,   Serbia,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom
 
NCT00840086
NN7008-3543, 2008-003960-20, 101151
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Sofia Jonhede Novo Nordisk A/S
Study Director: Anne Vedsø Novo Nordisk A/S
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP