Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors (adept™2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01392547
First received: July 8, 2011
Last updated: June 16, 2014
Last verified: June 2014

July 8, 2011
June 16, 2014
July 2011
August 2012   (final data collection date for primary outcome measure)
Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given [ Time Frame: Within 12 hours of first trial product administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01392547 on ClinicalTrials.gov Archive Site
  • Effective and Sustained Bleeding Control [ Time Frame: Up to 48 hours after first trial product administration ] [ Designated as safety issue: No ]
  • Number of Doses of Trial Product Given for Each Acute Bleed [ Time Frame: Up to 6 hours after first trial product administration ] [ Designated as safety issue: No ]
  • Number of Adverse Events [ Time Frame: Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product. ] [ Designated as safety issue: No ]
    Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
  • Immunogenicity [ Time Frame: Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product. ] [ Designated as safety issue: No ]
    Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or rFVIIa.
  • Effective and sustained bleeding control [ Time Frame: Up to 48 hours after first trial product administration ] [ Designated as safety issue: No ]
  • Number of doses of trial product given for each acute bleed [ Time Frame: Up to 6 hours after first trial product administration ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: After approximately 21 months (at end of trial) ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: After approximately 21 months (at end of trial) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors
Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients With Congenital Haemophilia and Inhibitors

This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Congenital Bleeding Disorder
  • Haemophilia A With Inhibitors
  • Haemophilia B With Inhibitors
  • Drug: vatreptacog alfa (activated)
    1-3 doses per bleeding episode
  • Drug: eptacog alfa (activated)
    1-3 doses per bleeding episode
  • Experimental: rFVIIa
    Intervention: Drug: eptacog alfa (activated)
  • Experimental: vatreptocog alfa
    Intervention: Drug: vatreptacog alfa (activated)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
  • Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial entry

Exclusion Criteria:

  • Previous participation in this trial defined as withdrawal after administration of trial product
  • Patient has received an investigational medicinal product within 30 days prior to this trial
  • Congenital or acquired coagulation disorders other than haemophilia A or B
  • Any clinical signs or known history of arterial thrombotic events or of deep venous thrombosis or pulmonary embolism (as defined by available medical records)
  • Platelet count of less than 50,000 platelets/mcL (at the screening visit)
  • ALAT (alanine-transaminase) of more than 3 times the upper normal limit (according to laboratory reference ranges)
  • Factor VIII/IX Immune Tolerance Induction regimen planned to occur during the trial
  • Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial
  • HIV (Human Immunodeficiency Virus) positive with current CD4+ count of less than 200/mcL (defined by medical records)
Male
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Brazil,   Croatia,   Greece,   Hungary,   Italy,   Japan,   Malaysia,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   South Africa,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT01392547
NN1731-3562, 2010-023803-92, U1111-1118-2228, JapicCTI-111595
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Silke Ehrenforth Novo Nordisk A/S
Novo Nordisk A/S
June 2014

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