Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773 (paradigm™ 4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01395810
First received: June 30, 2011
Last updated: April 7, 2014
Last verified: April 2014

June 30, 2011
April 7, 2014
April 2012
March 2014   (final data collection date for primary outcome measure)
Incidence of inhibitory antibodies against FIX defined as titre above or equal to 0.6 BU (Bethesda Units) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]
Incidence of inhibitory antibodies against FIX defined as titre above or equal to 0.6 BU (Bethesda Units) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion - up to 4 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01395810 on ClinicalTrials.gov Archive Site
  • Haemostatic effect of NNC-0156-0000-0009 when used for treatment of bleeding episodes, assessed as success/failure based on a four-point scale for haemostatic response (excellent, good moderate, poor) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]
  • Number of bleeding episodes during routine prophylaxis [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]
  • FIX trough levels [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion (up to 2 years) ] [ Designated as safety issue: No ]
  • Haemostatic effect of NNC-0156-0000-0009 when used for treatment of bleeding episodes, assessed as success/failure based on a four-point scale for haemostatic response (excellent, good moderate, poor) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion - up to 4 years ] [ Designated as safety issue: No ]
  • Number of bleeding episodes during routine prophylaxis [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion - up to 4 years ] [ Designated as safety issue: No ]
  • FIX trough levels [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion - up to 4 years ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events (AEs) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion - up to 4 years ] [ Designated as safety issue: No ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Every 3rd month the first year of trial, then every 6 months until trial completion - up to 4 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of NNC-0156-0000-0009 after long-term exposure in patients with haemophilia B.

This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).

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 B
  • Drug: NNC-0156-0000-0009
    One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience.
  • Drug: NNC-0156-0000-0009
    One single dose administered intravenously (into the vein). Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode.
  • Drug: NNC-0156-0000-0009
    One single dose administered intravenously (into the vein) every second week. Patients will receive instruction on how to treat any bleeding episode they may experience.
  • Experimental: Prophylaxis, high dose (once weekly)
    Intervention: Drug: NNC-0156-0000-0009
  • Experimental: Prophylaxis, low dose (once weekly)
    Intervention: Drug: NNC-0156-0000-0009
  • Experimental: On-demand
    Intervention: Drug: NNC-0156-0000-0009
  • Experimental: Prophylaxis, high dose (every second week)
    Intervention: Drug: NNC-0156-0000-0009
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previous participation in NN7999-3747 (NCT01333111) and/or NN7999-3773

Exclusion Criteria:

  • Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
  • Current FIX inhibitors above or equal to 0.6 BU (Bethesda Units)
  • Congenital or acquired coagulation disorders other than haemophilia B
  • Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
  • Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's (trial physician) judgement, could imply a potential hazard to the patient, interfere with trial participation, or interfere with trial outcome
Male
13 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   France,   Germany,   Greece,   Italy,   Japan,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Netherlands,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT01395810
NN7999-3775, 2010-023072-17, U1111-1121-5408, JapicCTI-121812
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
April 2014

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