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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01392547
First Posted: July 12, 2011
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Effective and Sustained Bleeding Control [ Time Frame: Up to 48 hours after first trial product administration ]
  • Number of Doses of Trial Product Given for Each Acute Bleed [ Time Frame: Up to 6 hours after first trial product administration ]
  • 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. ]
    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 (Inhibitor Development) [ 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. ]
    Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or FVII. Radioimmunoassay using [125I]-labelled vatreptacog alfa or rFVIIa was used to screen plasma samples for development of anti-drug antibodies


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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392547


  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Tucson, Arizona, United States, 85724-0001
United States, California
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90007
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90027
Novo Nordisk Clinical Trial Call Center
Orange, California, United States, 92868
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Aurora, Colorado, United States, 80045
United States, Florida
Novo Nordisk Clinical Trial Call Center
Tampa, Florida, United States, 33607
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30322
Novo Nordisk Clinical Trial Call Center
Augusta, Georgia, United States, 30912
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Novo Nordisk Clinical Trial Call Center
Boston, Massachusetts, United States, 02115
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Detroit, Michigan, United States, 48202-2608
United States, New York
Novo Nordisk Clinical Trial Call Center
Brooklyn, New York, United States, 11219
United States, Oregon
Novo Nordisk Clinical Trial Call Center
Portland, Oregon, United States, 97239
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23219
Austria
Linz, Austria, A 4020
Brazil
Campinas, Sao Paulo, Brazil, 13081970
Croatia
Zagreb, Croatia, 10 000
Greece
Athens, Greece, GR-11527
Hungary
Budapest, Hungary, H-1134
Italy
Milano, Italy, 20124
Japan
Shinjuku-ku, Tokyo, Japan, 160 0023
Malaysia
Kuala Lumpur, Malaysia, 50400
Poland
Warszawa, Poland, 02-776
Puerto Rico
Novo Nordisk Clinical Trial Call Center
San Juan, Puerto Rico, 00935
Romania
Timisoara, Timis, Romania, 300011
Russian Federation
Saint-Petersburg, Russian Federation, 191186
Serbia
Novi Sad, Serbia, 21000
South Africa
Parktown, Johannesburg, Gauteng, South Africa, 2193
Taiwan
Changhua, Taiwan, 500
Thailand
Bangkok, Thailand, 10400
Turkey
Bornova-IZMIR, Turkey, 35100
United Kingdom
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01392547     History of Changes
Other Study ID Numbers: NN1731-3562
2010-023803-92 ( EudraCT Number )
U1111-1118-2228 ( Other Identifier: WHO )
JapicCTI-111595 ( Registry Identifier: JAPIC )
First Submitted: July 8, 2011
First Posted: July 12, 2011
Results First Submitted: September 27, 2013
Results First Posted: December 6, 2013
Last Update Posted: May 15, 2017
Last Verified: February 2015

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