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Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects (guardian™1)

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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

12 Years - 65 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg
  • Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
  • No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A
  • No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)

Exclusion Criteria:

  • Congenital or acquired coagulation disorders other than haemophilia A
  • Creatinine levels 50% above normal level (as defined by central laboratory range)
  • Known or suspected allergy to trial product (N8) or related products

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
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  • Novo Nordisk Investigational Site
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  • 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
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  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
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  • 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 AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.

Full Information

First Posted
February 6, 2009
Last Updated
February 9, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00840086
Brief Title
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
Acronym
guardian™1
Official Title
A Multi-centre, Open-label, Non-controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 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 trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.

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
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rFVIII
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
turoctocog alfa
Intervention Description
Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.
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 188 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 AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Time Frame
The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds) No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening) Exclusion Criteria: Congenital or acquired coagulation disorders other than haemophilia A Creatinine levels 50% above normal level (as defined by central laboratory range) Known or suspected allergy to trial product (N8) or related products
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
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
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
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
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
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2168
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
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
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134-1095
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-9830
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
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rio de Janeiro
ZIP/Postal Code
20211-030
Country
Brazil
Facility Name
Novo Nordisk Investigational Site
City
Split
ZIP/Postal Code
21 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Novo Nordisk Investigational Site
City
København
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Former Serbia and Montenegro
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11070
Country
Former Serbia and Montenegro
Facility Name
Novo Nordisk Investigational Site
City
Nis
ZIP/Postal Code
18000
Country
Former Serbia and Montenegro
Facility Name
Novo Nordisk Investigational Site
City
Novi Sad
ZIP/Postal Code
21 000
Country
Former Serbia and Montenegro
Facility Name
Novo Nordisk Investigational Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Former Serbia and Montenegro
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
H-1134
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Hiroshima-shi, Hiroshima
ZIP/Postal Code
734 8551
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Itabashi-ku, Tokyo
ZIP/Postal Code
173 8606
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kashihara-shi, Nara
ZIP/Postal Code
634 8522
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Maebashi-shi, Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Nagoya-shi, Aichi
ZIP/Postal Code
466 8560
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shimotsuke-shi, Tochigi
ZIP/Postal Code
329 0498
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shinjuku-ku, Tokyo
ZIP/Postal Code
160 0023
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Shizuoka-shi, Shizuoka
ZIP/Postal Code
4208660
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Suginami-ku, Tokyo
ZIP/Postal Code
1670035
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
50400
Country
Malaysia
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
Belgrade
ZIP/Postal Code
11070
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Taipei
ZIP/Postal Code
100
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
Facility Name
Novo Nordisk Investigational Site
City
Samsun
ZIP/Postal Code
55319
Country
Turkey
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23647704
Citation
Lentz SR, Misgav M, Ozelo M, Salek SZ, Veljkovic D, Recht M, Cerqueira M, Tiede A, Brand B, Mancuso ME, Seremetis S, Lindblom A, Martinowitz U. Results from a large multinational clinical trial (guardian1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013 Sep;19(5):691-7. doi: 10.1111/hae.12159. Epub 2013 May 7.
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
25677761
Citation
Ozelo M, Chowdary P, Regnault A, Busk AK. Impact of severe haemophilia A on patients' health status: results from the guardian() 1 clinical trial of turoctocog alfa (NovoEight((R)) ). Haemophilia. 2015 Jul;21(4):451-7. doi: 10.1111/hae.12617. Epub 2015 Feb 12.
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

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Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

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