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: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Drug: vatreptacog alfa (activated)
Drug: eptacog alfa (activated)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients With Congenital Haemophilia and Inhibitors

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 72
Study Start Date: July 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rFVIIa Drug: eptacog alfa (activated)
1-3 doses per bleeding episode
Experimental: vatreptocog alfa Drug: vatreptacog alfa (activated)
1-3 doses per bleeding episode

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392547

  Show 32 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Silke Ehrenforth Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01392547     History of Changes
Other Study ID Numbers: NN1731-3562, 2010-023803-92, U1111-1118-2228, JapicCTI-111595
Study First Received: July 8, 2011
Results First Received: September 27, 2013
Last Updated: October 8, 2013
Health Authority: Austria: Agency for Health and Food Safety
Brazil: National Health Surveillance Agency
Croatia: Ministry of Health and Social Care
Greece: Ministry of Health
Hungary: Ministry of Health, Social and Family Affairs
Italy: The Italian Medicines Agency
Japan: Ministry of Health, Labor and Welfare
Malaysia: Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Federal Service for Control of Health Care and Social Development
Serbia: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
Taiwan: Department of Health
Thailand: Thai FDA
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia B
Hemophilia A
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014