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

March 29, 2017 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, A 4020
  • Brazil
    • Sao Paulo
      • 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
      • San Juan, Puerto Rico, 00935
        • Novo Nordisk Clinical Trial Call Center
  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300011
  • Russian Federation
      • Saint-Petersburg, Russian Federation, 191186
  • Serbia
      • Novi Sad, Serbia, 21000
  • South Africa
    • Gauteng
      • 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
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724-0001
        • Novo Nordisk Clinical Trial Call Center
    • California
      • 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
        • Novo Nordisk Clinical Trial Call Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Clinical Trial Call Center
    • Florida
      • Tampa, Florida, United States, 33607
        • Novo Nordisk Clinical Trial Call Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novo Nordisk Clinical Trial Call Center
      • Augusta, Georgia, United States, 30912
        • Novo Nordisk Clinical Trial Call Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Clinical Trial Call Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Novo Nordisk Clinical Trial Call Center
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Novo Nordisk Clinical Trial Call Center
    • New York
      • Brooklyn, New York, United States, 11219
        • Novo Nordisk Clinical Trial Call Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Clinical Trial Call Center
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Novo Nordisk Clinical Trial Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given
Time Frame: Within 12 hours of first trial product administration
Within 12 hours of first trial product administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective and Sustained Bleeding Control
Time Frame: Up to 48 hours after first trial product administration
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
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.
Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1731-3562
  • U1111-1118-2228 (Other Identifier: WHO)
  • 2010-023803-92 (EudraCT Number)
  • JapicCTI-111595 (Registry Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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