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Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A (guardian™ 3)

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
turoctocog alfa
turoctocog alfa
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

undefined - 11 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A
  • Age below 12 years and weight at least 11 kg

Exclusion Criteria:

  • Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures)
  • Congenital or acquired coagulation disorders other than haemophilia A
  • Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rFVIII

Arm Description

Outcomes

Primary Outcome Measures

The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))
The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.

Secondary Outcome Measures

Frequency of Adverse Events (AEs)
Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

Full Information

First Posted
May 28, 2010
Last Updated
February 9, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01138501
Brief Title
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
Acronym
guardian™ 3
Official Title
A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Previously Treated Paediatric Patients With Haemophilia A
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (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 in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rFVIII
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
turoctocog alfa
Intervention Description
Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.
Intervention Type
Drug
Intervention Name(s)
turoctocog alfa
Intervention Description
Subjects will undergo half-life evaluation of their current factor VIII product and pharmacokinetic session with turoctocog alfa before entering preventive treatment (subjects with available evaluation of terminal half-life within the last year are to be excluded from receiving factor VIII). Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.
Primary Outcome Measure Information:
Title
The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))
Description
The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.
Time Frame
The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject.
Secondary Outcome Measure Information:
Title
Frequency of Adverse Events (AEs)
Description
Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Time Frame
The adverse events were collected throughout the trial, corresponding to an average of 138 days per subject

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A Age below 12 years and weight at least 11 kg Exclusion Criteria: Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures) Congenital or acquired coagulation disorders other than haemophilia A Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)
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 Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502-2004
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108-4619
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2168
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201-5425
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80250-060
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13081970
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Shizuoka-shi, Shizuoka
ZIP/Postal Code
4208660
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Vilnius
ZIP/Postal Code
LT-08406
Country
Lithuania
Facility Name
Novo Nordisk Investigational Site
City
Skopje
ZIP/Postal Code
1000
Country
Macedonia, The Former Yugoslav Republic of
Facility Name
Novo Nordisk Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
00-576
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Wroclaw
ZIP/Postal Code
50-345
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Novo Nordisk Investigational Site
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Antalya
ZIP/Postal Code
01010
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Bornova-IZMIR
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
Izmit
ZIP/Postal Code
41380
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
23651313
Citation
Kulkarni R, Karim FA, Glamocanin S, Janic D, Vdovin V, Ozelo M, Rageliene L, Carboni E, Laguna P, Dobaczewski G, Seremetis S, Lindblom A, Santagostino E. Results from a large multinational clinical trial (guardian3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013 Sep;19(5):698-705. doi: 10.1111/hae.12165. Epub 2013 May 8.
Results Reference
result
PubMed Identifier
25273984
Citation
Santagostino E, Lentz SR, Misgav M, Brand B, Chowdary P, Savic A, Kilinc Y, Amit Y, Amendola A, Solimeno LP, Saugstrup T, Matytsina I. Safety and efficacy of turoctocog alfa (NovoEight(R)) during surgery in patients with haemophilia A: results from the multinational guardian clinical trials. Haemophilia. 2015 Jan;21(1):34-40. doi: 10.1111/hae.12518. Epub 2014 Oct 2.
Results Reference
result
PubMed Identifier
26679394
Citation
Ozelo MC. Updates from guardian: a comprehensive registration programme. Eur J Haematol. 2015 Dec;95 Suppl 81:22-9. doi: 10.1111/ejh.12648.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A

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