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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00840086
First received: February 6, 2009
Last updated: September 3, 2014
Last verified: September 2014

February 6, 2009
September 3, 2014
April 2009
September 2011   (final data collection date for primary outcome measure)
The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)) [ Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject. ] [ Designated as safety issue: No ]
The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.
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 (AEs) [ Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject ] [ Designated as safety issue: No ]
Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Inhibitor development [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of Turoctocog Alfa 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 Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes 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: turoctocog alfa
Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa 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.
Experimental: rFVIII
Intervention: Drug: turoctocog alfa
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:

  • Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg
  • Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
  • No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A
  • No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)

Exclusion Criteria:

  • Congenital or acquired coagulation disorders other than haemophilia A
  • Creatinine levels 50% above normal level (as defined by central laboratory range)
  • Known or suspected allergy to trial product (N8) or related products
Male
12 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Taiwan,   Switzerland,   Spain,   Serbia,   Russian Federation,   Malaysia,   Turkey,   Japan,   Brazil,   Croatia,   Germany,   Israel,   United Kingdom,   United States
 
NCT00840086
NN7008-3543, 2008-003960-20, 101151
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
September 2014

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