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: August 8, 2014
Last verified: August 2014
  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 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 8, 2014
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:
Hemorrhage
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014