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

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
vatreptacog alfa (activated)
eptacog alfa (activated)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center
  • Novo Nordisk Clinical Trial Call Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

rFVIIa

vatreptocog alfa

Arm Description

Outcomes

Primary Outcome Measures

Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given

Secondary Outcome Measures

Effective and Sustained Bleeding Control
Number of Doses of Trial Product Given for Each Acute Bleed
Number of Adverse Events
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)
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

Full Information

First Posted
July 8, 2011
Last Updated
March 29, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01392547
Brief Title
Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors
Acronym
adept™2
Official Title
Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients With Congenital Haemophilia and Inhibitors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rFVIIa
Arm Type
Experimental
Arm Title
vatreptocog alfa
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
vatreptacog alfa (activated)
Intervention Description
1-3 doses per bleeding episode
Intervention Type
Drug
Intervention Name(s)
eptacog alfa (activated)
Intervention Description
1-3 doses per bleeding episode
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Effective and Sustained Bleeding Control
Time Frame
Up to 48 hours after first trial product administration
Title
Number of Doses of Trial Product Given for Each Acute Bleed
Time Frame
Up to 6 hours after first trial product administration
Title
Number of Adverse Events
Description
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.
Time Frame
Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.
Title
Immunogenicity (Inhibitor Development)
Description
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
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-0001
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Novo Nordisk Clinical Trial Call Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
City
Linz
ZIP/Postal Code
A 4020
Country
Austria
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13081970
Country
Brazil
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
City
Athens
ZIP/Postal Code
GR-11527
Country
Greece
City
Budapest
ZIP/Postal Code
H-1134
Country
Hungary
City
Milano
ZIP/Postal Code
20124
Country
Italy
City
Shinjuku-ku, Tokyo
ZIP/Postal Code
160 0023
Country
Japan
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Novo Nordisk Clinical Trial Call Center
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300011
Country
Romania
City
Saint-Petersburg
ZIP/Postal Code
191186
Country
Russian Federation
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
City
Parktown, Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bornova-IZMIR
ZIP/Postal Code
35100
Country
Turkey
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

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