Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects (guardian™1)
February 9, 2017 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
150
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
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Rio de Janeiro, Brazil, 20211-030
- Novo Nordisk Investigational Site
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Split, Croatia, 21 000
- Novo Nordisk Investigational Site
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Zagreb, Croatia, 10 000
- Novo Nordisk Investigational Site
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København, Denmark, 2100
- Novo Nordisk Investigational Site
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Belgrade, Former Serbia and Montenegro, 11000
- Novo Nordisk Investigational Site
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Belgrade, Former Serbia and Montenegro, 11070
- Novo Nordisk Investigational Site
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Nis, Former Serbia and Montenegro, 18000
- Novo Nordisk Investigational Site
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Novi Sad, Former Serbia and Montenegro, 21000
- Novo Nordisk Investigational Site
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Novi Sad, Former Serbia and Montenegro, 21 000
- Novo Nordisk Investigational Site
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Berlin, Germany, 10249
- Novo Nordisk Investigational Site
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Bonn, Germany, 53127
- Novo Nordisk Investigational Site
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Giessen, Germany, 35392
- Novo Nordisk Investigational Site
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Hannover, Germany, 30625
- Novo Nordisk Investigational Site
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Budapest, Hungary, H-1134
- Novo Nordisk Investigational Site
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Debrecen, Hungary, 4012
- Novo Nordisk Investigational Site
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Tel-Hashomer, Israel, 52621
- Novo Nordisk Investigational Site
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Firenze, Italy, 50134
- Novo Nordisk Investigational Site
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Milano, Italy, 20124
- Novo Nordisk Investigational Site
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Hiroshima-shi, Hiroshima, Japan, 734 8551
- Novo Nordisk Investigational Site
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Itabashi-ku, Tokyo, Japan, 173 8606
- Novo Nordisk Investigational Site
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Kashihara-shi, Nara, Japan, 634 8522
- Novo Nordisk Investigational Site
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Maebashi-shi, Gunma, Japan, 371-8511
- Novo Nordisk Investigational Site
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Nagoya-shi, Aichi, Japan, 466 8560
- Novo Nordisk Investigational Site
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Shimotsuke-shi, Tochigi, Japan, 329 0498
- Novo Nordisk Investigational Site
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Shinjuku-ku, Tokyo, Japan, 160 0023
- Novo Nordisk Investigational Site
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Shizuoka-shi, Shizuoka, Japan, 4208660
- Novo Nordisk Investigational Site
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Suginami-ku, Tokyo, Japan, 1670035
- Novo Nordisk Investigational Site
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Kuala Lumpur, Malaysia, 50400
- Novo Nordisk Investigational Site
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Saint-Petersburg, Russian Federation, 191119
- Novo Nordisk Investigational Site
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Belgrade, Serbia, 11000
- Novo Nordisk Investigational Site
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Belgrade, Serbia, 11070
- Novo Nordisk Investigational Site
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Nis, Serbia, 18000
- Novo Nordisk Investigational Site
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Novi Sad, Serbia, 21000
- Novo Nordisk Investigational Site
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Madrid, Spain, 28046
- Novo Nordisk Investigational Site
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Valencia, Spain, 46026
- Novo Nordisk Investigational Site
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Zürich, Switzerland, 8091
- Novo Nordisk Investigational Site
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Taipei, Taiwan, 100
- Novo Nordisk Investigational Site
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Adana, Turkey, 01130
- Novo Nordisk Investigational Site
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Antalya, Turkey, 01010
- Novo Nordisk Investigational Site
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Bornova-IZMIR, Turkey, 35100
- Novo Nordisk Investigational Site
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Izmit, Turkey, 41380
- Novo Nordisk Investigational Site
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Samsun, Turkey, 55319
- Novo Nordisk Investigational Site
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London, United Kingdom, NW3 2QG
- Novo Nordisk Investigational Site
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London, United Kingdom, SE1 7EH
- Novo Nordisk Investigational Site
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Manchester, United Kingdom, M13 9WL
- Novo Nordisk Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Novo Nordisk Investigational Site
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California
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Long Beach, California, United States, 90806
- Novo Nordisk Investigational Site
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Florida
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Tampa, Florida, United States, 33607
- Novo Nordisk Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30322
- Novo Nordisk Investigational Site
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Augusta, Georgia, United States, 30912
- Novo Nordisk Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46260
- Novo Nordisk Investigational Site
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Iowa
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Iowa City, Iowa, United States, 52242
- Novo Nordisk Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68198-2168
- Novo Nordisk Investigational Site
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New Jersey
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Newark, New Jersey, United States, 07102
- Novo Nordisk Investigational Site
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Ohio
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Cincinnati, Ohio, United States, 45229
- Novo Nordisk Investigational Site
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Dayton, Ohio, United States, 45404
- Novo Nordisk Investigational Site
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Oregon
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Portland, Oregon, United States, 97239
- Novo Nordisk Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19134-1095
- Novo Nordisk Investigational Site
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Novo Nordisk Investigational Site
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Tennessee
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Memphis, Tennessee, United States, 38163
- Novo Nordisk Investigational Site
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Nashville, Tennessee, United States, 37232-9830
- Novo Nordisk Investigational Site
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Texas
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Fort Worth, Texas, United States, 76104
- Novo Nordisk Investigational Site
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Washington
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Spokane, Washington, United States, 99204
- Novo Nordisk Investigational Site
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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 to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: rFVIII
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))
Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject.
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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.
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The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Frequency of Adverse Events (AEs)
Time Frame: The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject
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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.
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The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- 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.
- 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.
- 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.
- Ozelo MC. Updates from guardian: a comprehensive registration programme. Eur J Haematol. 2015 Dec;95 Suppl 81:22-9. doi: 10.1111/ejh.12648.
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
April 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
February 6, 2009
First Submitted That Met QC Criteria
February 9, 2009
First Posted (Estimate)
February 10, 2009
Study Record Updates
Last Update Posted (Actual)
March 17, 2017
Last Update Submitted That Met QC Criteria
February 9, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN7008-3543
- 2008-003960-20 (EudraCT Number)
- 101151 (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.